52 Clinical Trials jobs in Hyderabad

SUMMARY

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIURadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology.

Under the direction of Imaging Operations Management this position is responsible for conducting a variety of QC/analysis procedures and performing read assignment as per study-specific procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In addition, this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.

CLINICAL TRIAL IMAGING SPECIALIST

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform imaging data reconciliation per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Complete quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases reader for read assignment per the Standard Operating Procedure (SOP)and the Study Specific Procedures (SSP)
• Prepare study dossiers to be associated with read assignment per the SOP/SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Perform technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Maintain TMF and ensure appropriate study documents are filed for audit readiness
• Assist in the training of internal staff
• Other duties as assigned by manager

EDUCATION AND EXPERIENCE:

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Proficiency in MS Office and internet applications required
• Minimum of 2 years of experience in medical imaging required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred, i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

CLINICAL TRIAL IMAGING SPECIALIST II

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases ready for read assignment per the Standard Operating Procedure (SOP) and the Study Specific Procedures (SSP)
• Perform the project trainings for new team members and site trainings
• Prepare study dossiers to be associated with read assignment per the SOP/SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Communicate with readers about assigned reads, pending reads, and/or any other concerns when needed
• Communicate to the study team regarding issues that arise during the read assignment process
• Creation and/or review of image QC checklists, imaging manuals, site evaluation questionnaires, training material for imaging site personnel, and any other site required documents
• Perform technical training of imaging site personnel (on-site or telecon)
• Perform AG Mednet user acceptance testing (UAT) and documentation for new studies and enhancement for existing studies to confirm correct study set up
• Participate in the study related client and other meetings as and when required
• Assist with operational process improvements
• Perform other duties as assigned by manager

EDUCATION AND EXPERIENCE

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred
• Proficiency in MS Office and internet applications required
• Minimum of 3 years of experience in medical imaging required
• Minimum of 2 years of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of the drug development process and clinical trials process and/or experience working in a pharmaceutical environment preferred
• Knowledge of image trial documents strongly preferred, i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

SKILLS

• Proficiency in MS Office and internet applications
• Service-oriented approach, flexible, and proactive toward adapting to client needs
• Ability to manage project activities with diverse group and individuals with little supervision
• Must have superior attention to detail including excellent oral and written communication skills.
• Must have the ability to work independently, multitask, and meet critical timelines under pressure
• Must have strong time management and organization skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Ability to work in strict compliance with all procedures, rules, and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Ability to prioritize workload to the changing needs of the day-to-day business
• Ability to understand technical research protocols and successfully lead within the research environment

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure™ and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: 5 to 10% (domestic and/or international)

SUMMARY

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIURadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology.

Under the direction of Imaging Operations Management this position is responsible for conducting a variety of QC/analysis procedures and performing read assignment as per study-specific procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In addition, this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.

CLINICAL TRIAL IMAGING SPECIALIST

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform imaging data reconciliation per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Complete quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases reader for read assignment per the Standard Operating Procedure (SOP)and the Study Specific Procedures (SSP)
• Prepare study dossiers to be associated with read assignment per the SOP/SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Perform technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Maintain TMF and ensure appropriate study documents are filed for audit readiness
• Assist in the training of internal staff
• Other duties as assigned by manager

EDUCATION AND EXPERIENCE:

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Proficiency in MS Office and internet applications required
• Minimum of 2 years of experience in medical imaging required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred, i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

CLINICAL TRIAL IMAGING SPECIALIST II

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases ready for read assignment per the Standard Operating Procedure (SOP) and the Study Specific Procedures (SSP)
• Perform the project trainings for new team members and site trainings
• Prepare study dossiers to be associated with read assignment per the SOP/SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Communicate with readers about assigned reads, pending reads, and/or any other concerns when needed
• Communicate to the study team regarding issues that arise during the read assignment process
• Creation and/or review of image QC checklists, imaging manuals, site evaluation questionnaires, training material for imaging site personnel, and any other site required documents
• Perform technical training of imaging site personnel (on-site or telecon)
• Perform AG Mednet user acceptance testing (UAT) and documentation for new studies and enhancement for existing studies to confirm correct study set up
• Participate in the study related client and other meetings as and when required
• Assist with operational process improvements
• Perform other duties as assigned by manager

EDUCATION AND EXPERIENCE

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred
• Proficiency in MS Office and internet applications required
• Minimum of 3 years of experience in medical imaging required
• Minimum of 2 years of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of the drug development process and clinical trials process and/or experience working in a pharmaceutical environment preferred
• Knowledge of image trial documents strongly preferred, i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

SKILLS

• Proficiency in MS Office and internet applications
• Service-oriented approach, flexible, and proactive toward adapting to client needs
• Ability to manage project activities with diverse group and individuals with little supervision
• Must have superior attention to detail including excellent oral and written communication skills.
• Must have the ability to work independently, multitask, and meet critical timelines under pressure
• Must have strong time management and organization skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Ability to work in strict compliance with all procedures, rules, and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Ability to prioritize workload to the changing needs of the day-to-day business
• Ability to understand technical research protocols and successfully lead within the research environment

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure™ and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: 5 to 10% (domestic and/or international)

SUMMARY

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts;
London, UK;
Leiden, Netherlands;
Basel, Switzerland;
Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIURadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology.

Under the direction of Imaging Operations Management this position is responsible for conducting a variety of QC/analysis procedures and performing read assignment as per study-specific procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In addition, this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.

CLINICAL TRIAL IMAGING SPECIALIST

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform imaging data reconciliation per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Complete quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases reader for read assignment per the Standard Operating Procedure (SOP)and the Study Specific Procedures (SSP)
• Prepare study dossiers to be associated with read assignment per the SOP/SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Perform technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Maintain TMF and ensure appropriate study documents are filed for audit readiness
• Assist in the training of internal staff
• Other duties as assigned by manager

EDUCATION AND EXPERIENCE:

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Proficiency in MS Office and internet applications required
• Minimum of 2 years of experience in medical imaging required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred, i.E. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

CLINICAL TRIAL IMAGING SPECIALIST II

RESPONSIBILITIES:

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Generate, track, and resolve image queries to address technical issues in a timely manner
• Identify and assign cases ready for read assignment per the Standard Operating Procedure (SOP) and the Study Specific Procedures (SSP)
• Perform the project trainings for new team members and site trainings
• Prepare study dossiers to be associated with read assignment per the SOP/SSP
• Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS)
• Communicate with readers about assigned reads, pending reads, and/or any other concerns when needed
• Communicate to the study team regarding issues that arise during the read assignment process
• Creation and/or review of image QC checklists, imaging manuals, site evaluation questionnaires, training material for imaging site personnel, and any other site required documents
• Perform technical training of imaging site personnel (on-site or telecon)
• Perform AG Mednet user acceptance testing (UAT) and documentation for new studies and enhancement for existing studies to confirm correct study set up
• Participate in the study related client and other meetings as and when required
• Assist with operational process improvements
• Perform other duties as assigned by manager

EDUCATION AND EXPERIENCE

• Bachelor's degree in a science or health related field or Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred
• Proficiency in MS Office and internet applications required
• Minimum of 3 years of experience in medical imaging required
• Minimum of 2 years of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of the drug development process and clinical trials process and/or experience working in a pharmaceutical environment preferred
• Knowledge of image trial documents strongly preferred, i.E. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.

SKILLS

• Proficiency in MS Office and internet applications
• Service-oriented approach, flexible, and proactive toward adapting to client needs
• Ability to manage project activities with diverse group and individuals with little supervision
• Must have superior attention to detail including excellent oral and written communication skills.
• Must have the ability to work independently, multitask, and meet critical timelines under pressure
• Must have strong time management and organization skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Ability to work in strict compliance with all procedures, rules, and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Ability to prioritize workload to the changing needs of the day-to-day business
• Ability to understand technical research protocols and successfully lead within the research environment

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure™ and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
• Integrity and high ethical standards;
  we always do the right thing
• High intellect and ingenuity;
  we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated;
  we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE everyday
• Accountable;
  we do what we say and communicative effectively to meet deadlines;
  we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence;
  we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel;
reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: 5 to 10% (domestic and/or international)

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts;
London, UK;
Leiden, Netherlands;
Basel, Switzerland;
Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology.

The Nuclear Medicine Imaging Scientist is primarily responsible for conducting a variety of QC/analysis procedures and providing medical writing support at a clinical trial level. This person is responsible for reviewing the imaging data received from the clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In addition, this person will assist in project management duties within the operations and medical scientific affairs departments and serve as the imaging technical support for internal and external staff. The Nuclear Medicine Imaging Scientist shall interact with external clients, internal team members, Key Opinion Leaders (KOLs), and Physician Consultant/Contracted reviewers around the development of required clinical trial documents when required. The Nuclear Medicine Imaging Scientist is responsible for assisting in the delivery of IE's central reader training, study procedures and protocol criteria when required.

RESPONSIBILITIES

• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform Imaging data reconstruction per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Complete quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate image queries to address technical issues, track those issues and ensure timely resolution
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel including Data Transmittal Form, Imaging Manual, Site Training slides, and other supplemental documents as needed
• Technical training of imaging site personnel (on-site or telecon)
• Develop Image QC Checklists for all studies with Nuclear Medicine as modality and assigned studies.
• Collaborate with project internal teams to support sponsor specified project scope of work as required
• Provide medical and scientific input to the following documents as necessary/applicable.

>
Project Management Plans

>
Imaging Review Charters

>
Reader Rules

>
Image Analysis Platform

>
Final Study Reports

>
Clinical Case Report Forms

>
Study Protocols

• Provide training to Radiologist, Oncologist, and other sub-specialty Physicians on

>
Imaging Review Charters/Reader Rules

>
Reader Rules

>
Image Analysis Platform

>
Protocol-specific assessment criteria

• Monitor/evaluate reader results to ensure compliance with protocol criteria and CRF completion requirements
• Mentor and assist in the training of internal staff
• Other duties as assigned by manager

EDUCATION AND EXPERIENCE

• Registered Nuclear Medicine Technologist
• Knowledge of PET/CT imaging systems required
• Knowledge of SPECT imaging systems preferred
• Associates or Bachelor's degree preferred
• Minimum of 3 years' experience as a nuclear medicine technologist required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred, i.E., Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.
• Prior Project Management duties preferred, i.E., driving timelines, deliverables and managing concurrent priorities

SKILLS

• Service oriented approach, flexible and proactive with ability to think tactically and strategically
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to develop and drive project timelines
• Must be self-motivated and able to grasp new concepts quickly

• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills
• The ability to communicate clearly, concisely, and frequently and know when to use email, schedule meetings or conduct one-on-one conversations
• Prioritizing workload to the changing needs of the day-to-day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules, and regulations
• Work precisely according to all procedures, rules, and regulations
• Proficiency in MS Office and internet applications
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Ability to motivate others and keep project teams working effectively
• Possess the skills required to keep senior leadership informed to support business making decisions
• Ability to understand technical research protocols and successfully lead within the research environment, when required

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure™ and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
• Integrity and high ethical standards;
  we always do the right thing
• High intellect and ingenuity;
  we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated;
  we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE everyday
• Accountable;
  we do what we say and communicative effectively to meet deadlines;
  we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence;
  we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel;
reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: Up to 10 - 15% travel (Domestic and International)

Global Study Supply Support (GSSS)

Location: Hyderabad

Experience: 2–7 years

Choosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading Consumer Products and Retail Services (CPRS) organizations unlock the value of technology and drive scalable, sustainable growth.

Join a team that supports global clinical trials across phases I to IV, ensuring investigational product (IP) supply and compliance with regulatory standards. As a GSSS, you’ll play a key role in operational excellence, working closely with Clinical Supply Chain Study Leaders (CSC SL) and cross-functional teams.

Your Role

As a Global Study Supply Support (GSSS), you will support the Clinical Supply Chain Study Leader (CSC SL) throughout the lifecycle of clinical studies—from setup to close-out. You’ll manage investigational product logistics, documentation, and compliance activities, ensuring smooth execution of clinical trials.

In this role, you will:

Study Set-up

• Manage Trial Master File (TMF) documentation and ensure inspection readiness.
• Prepare shipment documentation including customs and country-specific requirements.
• Support Clinical Supply Packaging Order (CSPO) management.

Study Follow-up

• Enter and track shipment orders in supply systems.
• Monitor stock levels and IRT interface failures.
• Manage expired IMP and AxMP destruction processes.
• Extract temperature excursion data and support financial tracking.
• Ensure accurate data entry for packaging and distribution.

Study Close-out

• Coordinate returns and destruction of IP.
• Manage IP reconciliation with IPM.
• Generate Clinical Study Report (CSR) appendices.
• Ensure proper study documentation closure.

Your Profile

• Strong understanding of clinical trial protocols, regulatory requirements (GxP), and investigational product management.
• Familiarity with patient randomization, dosing regimens, and cohort management.
• Experience in IP logistics including kit types, shelf life, depot management, and reconciliation.
• Detail-oriented with strong documentation and coordination skills.
• Ability to work independently across multiple studies and stakeholders.

Tools You’ll Use

• eTMF, Veeva Vault
• RAID, IRT (Suvoda, Endpoint, Almac, Parexel)
• Clicks, QUALIPSO (CAPA tool)
• TEX (Temperature Excursion Management Tool)

What You’ll Love About Working Here

• Be part of a global team driving innovation in clinical research.
• Work in a collaborative environment with opportunities for learning and growth.
• Contribute to life-changing therapies by ensuring clinical supply chain excellence.

About Us

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

SUMMARY

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts;
London, UK;
Leiden, Netherlands;
Basel, Switzerland;
Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

Under the direction of Imaging Operations Management this position is responsible to work with the Operations staff, Sponsor staff, and study sites in coordinating clinical project activities. The Clinical Project Coordinator / Clinical Project Coordinator II / Lead Clinical Project Coordinator requires skill similar to a Clinical Research Coordinator (CRC) but does not have direct patient interaction.

CLINICAL PROJECT COORDINATOR

RESPONSIBILITIES

• Site evaluations

Following standard operating procedures evaluate sites for capability to participate in the imaging in assigned trials

Escalate site evaluation issues to Project Manager (PM)

Schedule and coordinate site trainings

Primary contact for clinical trial site activities

Maintaining Project Tracker

• Trial Master File (TMF) owner

Maintain TMF and ensure project documents are complete, current, and stored appropriately according to SOPs

Document the discrepancies are remediation plans and instruct appropriate department on the correction required

• Audit preparation and readiness activities

Provide study documents for audit to the study compliance team member as required

Verify all processes and procedures to maintain compliant standards of the study

• Verification of PM activities for study and read start up

Provide direction on compliance per company SOPs on to study readiness for the appropriate stage of the clinical trial

Direct PM on remediation of outstanding issues

• Assist PM with other project start-up activities and throughout the life cycle of the project
• Ensure timely updates to project tracker, including study enrollment
• Perform User Acceptance Testing as assigned by supervisor
• Tracking scans received on CD or SFTP to upload into PACS-RAW repository using AG Mednet or as applicable
• Provide pre-processing help for CTIS tasks, such as DTF downloads to the study repository
• Track, data-enter, and manage Case Report Forms (CRFs), queries, and clinical data flow
• Convert clinical dossiers for reader assignments per SSPs
• Report on project status to client and management;
  generate weekly status,site, and enrollment reports
• Contact sites for query and data follow up
• Schedule project meetings, generate agendas and document meeting minutes
• Understand and comply with protocol guidelines and requirements of regulatory agencies
• Maintain confidentiality and adhere to HIPAA regulations
• Perform other duties as assigned by supervisor

EDUCATION AND EXPERIENCE

• Bachelor’s degree required
• Experience in the medical or clinical trials industry is preferred (other healthcare or related experience is also an asset)
• Prior experience as Clinical Research Coordinators (CRC) would be preferred for this position
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Has strong organizational and time management skills
• Proficiency in MS Office and internet applications required

CLINICAL PROJECT COORDINATOR II

RESPONSIBILITIES

• Coordinate & collaborate with PMs for the site list, updating the site contact details and granting relevant system access (AG Mednet, CTMS)
• Site evaluations

Following Standard operating procedures evaluate sites for capability to participate in

the imaging in assigned trials

Escalate site evaluation issues to Project Manager (PM)

Schedule and coordinate site trainings

Act as primary contact for clinical trial site activities

• Trial Master File (TMF) owner

Maintain TMF and ensure project documents are complete, current, and stored

appropriately according to SOPs

Document the discrepancies and remediation plans and instruct appropriate

department on the correction required

• Responsible for audit readiness of assigned trials

Provide study documents for audit to Study Compliance member as needed

Verify all processes and procedures to maintain compliant standards of the study

• Verification of PM activities for study and read start up

Provide direction on compliance per company SOPs on to study readiness for the

appropriate stage of the clinical trial

Direct PM on remediation of outstanding issues

• Training and mentoring

Train the new CPCs on the CPC tasks and mentor them as they are assigned to

various trials

• Study Closeout activities

Complete all tasks related to the study closeout by coordinating with the project team

and update PM regularly

Ensure alignment of closeout timelines and communicate effectively through the

duration of the closeout activity for the trial

• Effectively communicate all clinical project related information including the planning and execution of study-related meetings and presentations
• Assist PM with other project start-up activities and throughout the life cycle of the project
• Ensure timely updates to project tracker, including study enrollment
• Perform User Acceptance Testing and Image Reconciliation as assigned by supervisor
• Tracking scans received on CD or SFTP to upload into PACS-RAW repository using AG Mednet or as applicable
• Provide pre-processing help for CTIS tasks, such as DTF downloads to the study repository
• Track, data-enter and manage Case Report Forms (CRFs), queries and clinical data flow
• Convert clinical dossiers for reader assignments per SSPs
• Report on project status to client and management;
  generate weekly status,site, and enrollment reports
• Contact sites for query and data follow up
• Perform Image reconciliation as assigned by supervisor
• Schedule project meetings, generate agendas and document meeting minutes
• Understand and comply with protocol guidelines and requirements of regulatory agencies
• Maintain confidentiality and adhere to HIPAA regulations

Perform other duties as assigned by supervisor

EDUCATION AND EXPERIENCE

• Bachelor’s degree required
• Minimum of 1 year of experience in the medical or clinical trials industry is preferred (other healthcare or related experience is also an asset)
• Prior experience as Clinical Research Coordinators (CRC) would be preferred for this position
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Has strong organizational and time management skills
• Proficiency in MS Office and internet applications required

SKILLS

• Proficiency in MS Office and internet applications
• Service-oriented approach, flexible, and proactive toward adapting to client needs
• Ability to manage project activities with diverse group and individuals with little supervision
• Must have superior attention to detail including excellent oral and written communication skills
• Must have the ability to work independently, multitask, and meet critical timelines under pressure
• Must have strong time management and organization skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Ability to work in strict compliance with all procedures, rules, and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Ability to prioritize workload to the changing needs of the day-to-day business
• Ability to understand technical research protocols and successfully lead within the research environment

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
• Integrity and high ethical standards;
  we always do the right thing
• High intellect and ingenuity;
  we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated;
  we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday
• Accountable;
  we do what we say and communicative effectively to meet deadlines;
  we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence;
  we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM . Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts;
London, UK;
Leiden, Netherlands;
Basel, Switzerland;
Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

The Senior Director / Vice President (VP), Imaging Operations Asia is primarily responsible for the management of the Imaging Operations (iOPs) department including Clinical Trials Imaging Specialists (CTIS), Clinical Project Coordinators (CPC) and Imaging Clinical Trial Management System (iCTMS) team members in Asia, with potential team members in other regions as applicable. The role shall provide directions to the Imaging Operations staff, mentor and lead the Imaging Operations team, and ensure adherence to quality management practices.

RESPONSIBILITIES

• Review and optimize processes, procedures, training, support, oversight, and performance within the iOPs department to ensure optimal delineation of departmental responsibilities, intra/inter-departmental workflows, and the overall efficiency and compliance of all activities across the continuum of iCRO services from work order to study startup, study conduct and study closure.
• Optimize departmental structure and create a highly desired work environment for attracting and retaining highly qualified professionals.
• Identify and assist in filling supervisor’s and staff needs. Mentor, robustly train, and provide development for supervisors and staff.
• Lead the Imaging operations team to optimize procedures for enhancing department compliance and efficiency. Oversee day-to-day aspects of Imaging Operations staff to ensure robust processes that are followed consistently.
• Development and maintenance of robust procedures, including study specific procedures
• Effective training and training verification with ongoing support
• Rigorous daily oversight of staff with effective escalation for team members’ needs and questions
• Periodic monitoring, pursuant to robust procedures, of the suitability of procedures and staff’s compliance to procedures
• Lead the imaging operations team (CTIS, iCTMS, and CPC) to identify and develop efficient systems for enhancing department efficiency. Assist with the development, validation, operation, and controlled state of systems. Assist IT with the development, validation, operation, and controlled state of IT systems as it relates to iOPs.
• Ensure optimal intra and inter-departmental coordination and project plan development/maintenance through resource and priority planning, priority clarity, issue escalation boundaries and pathways, and effective, regular communication channels.
• Manage the department to ensure adherence to and compliance with applicable regulations, accreditation requirements, and guidance from regulatory agencies.
• Work with finance and executive management to accurately forecast and track applicable WO line items for revenue and expenses to maximize revenue and minimize operations costs.
• Represent iOPs in client meetings/presentations and/or audits and inspections, as required.
• Responsible for study status reporting to the client and management.
• Any other duties as deemed applicable by the head of Imaging Operations

EDUCATION AND EXPERIENCE

• Masters’ degree or equivalent (preferably in Business Administration, Healthcare Management or Sciences)
• Minimum of 8 years of experience in clinical research operations , including experience in a leadership role (12 years for VP role )
• Minimum of 6 years of experience in the imaging CRO industry (10 years for VP role )

SKILLS

• Excellent verbal and written English communication skills.
• Highest standard for self-excellence, and ability to inspire and ensure excellence from others
• Must have superior attention to detail and excellent oral and written communication skills
• Hands-on ability to think strategically and tactically
• Work precisely with excellence according to all procedures, rules, and regulations
• Ability to understand complex research protocols and successfully lead within the iCRO regulated environment
• Provide staff with appropriate coaching, mentoring, and development to achieve excellence
• Ability to manage project activities with diverse groups and individuals
• Service oriented approach, flexible, and proactive towards adapting to clients’ needs
• Prioritize workload to the changing needs of the day-to-day business
• Must have the ability to multitask and work under pressure
• Must have excellent time management and organizational skills;
  ability to excel in a complex business and team environment
• Must be self-motivated and able to grasp new concepts and operationalize new needs quickly
• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Proficiency in MS Office, internet applications, image transmission, image processing, image analysis, and clinical trial management systems
• Self-driven, ability to get the job done, can-do positive attitude

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
• Integrity and high ethical standards;
  we always do the right thing
• High intellect and ingenuity;
  we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated;
  we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday
• Accountable;
  we do what we say and communicative effectively to meet deadlines;
  we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence;
  we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel;
reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: 10 - 20% travel (Domestic and International)