977 Clinical Data Managers jobs in India

Clinical Research Associate (Clinical Trials)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

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Job Description

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Nagpur
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate (Clinical Trials)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Bangalore
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate (Clinical Trials)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Bangalore
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate (Clinical Trials)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Hyderabad
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate (Clinical Trials)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Hyderabad
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate (Clinical Trials)

Sun Pharmaceuticals, Inc

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Kolkata
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
This advertiser has chosen not to accept applicants from your region.

Clinical Research Manager

208001 Kanpur, Uttar Pradesh ₹1200000 Annually WhatJobs

Posted 22 days ago

Job Viewed

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Job Description

full-time
Our client, a leading pharmaceutical innovator, is seeking an experienced Clinical Research Manager to oversee and direct clinical trial operations in Kanpur, Uttar Pradesh, IN . The ideal candidate will have a strong background in clinical research management, with extensive knowledge of GCP, ICH guidelines, and regulatory requirements. You will be responsible for planning, implementing, and monitoring clinical trials from initiation to closure, ensuring adherence to protocols, timelines, and budgets. Key responsibilities include managing clinical research associates (CRAs), site staff, and external vendors, as well as ensuring data integrity and patient safety. You will also play a crucial role in protocol development, site selection, and regulatory submissions. The ability to lead and motivate a team, manage multiple projects simultaneously, and strong problem-solving skills are essential. A Master's degree in a life science, nursing, or a related field, along with a minimum of 5-7 years of progressive experience in clinical research, is required. Experience with various therapeutic areas is a plus. This position offers a competitive compensation package, excellent benefits, and the opportunity to contribute to the development of life-saving therapies. We are looking for a detail-oriented, organized, and proactive individual with excellent communication and leadership skills. Your expertise will be vital in ensuring the successful execution of our clinical development programs. The role requires a strategic thinker capable of anticipating and mitigating potential risks in clinical trial conduct. You will be instrumental in fostering strong relationships with clinical investigators and site personnel, ensuring optimal trial performance. Prior experience in managing Phase II/III trials is highly desirable.
This advertiser has chosen not to accept applicants from your region.
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Clinical Research Associate - Pharmaceutical Trials

400001 Mumbai, Maharashtra ₹70000 Annually WhatJobs

Posted 9 days ago

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Job Description

full-time
Our client, a pioneering pharmaceutical company, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their expanding clinical operations team. This role offers a hybrid work arrangement, allowing for a blend of remote flexibility and essential on-site collaboration. As a CRA, you will play a pivotal role in ensuring the successful execution of clinical trials in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements. Your responsibilities will encompass site selection, initiation, monitoring, and close-out activities. You will be responsible for verifying data accuracy and integrity by reviewing source documents, conducting site visits (both in-person and remotely), and ensuring compliance with study protocols. This includes managing patient recruitment, adverse event reporting, and maintaining accurate study documentation. Exceptional communication and interpersonal skills are vital, as you will serve as the primary liaison between the investigational sites, the sponsor, and regulatory authorities. You will be expected to provide training and ongoing support to clinical site staff, fostering strong working relationships. The ideal candidate will possess a strong understanding of pharmaceutical drug development processes, regulatory affairs, and clinical trial methodologies. A proactive approach to identifying and resolving site-specific issues is crucial. You should be adept at managing multiple priorities and adhering to strict deadlines in a fast-paced environment. Responsibilities:
  • Conduct site initiation, interim monitoring, and close-out visits.
  • Verify accuracy and completeness of clinical trial data through source document review.
  • Ensure compliance with study protocols, GCP, and regulatory requirements.
  • Manage and maintain essential study documents.
  • Serve as the primary point of contact for assigned investigational sites.
  • Train and support site personnel on study procedures.
  • Monitor patient recruitment and retention efforts.
  • Report and track adverse events and deviations.
  • Collaborate with project management and other study team members.
Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Previous experience as a Clinical Research Associate (CRA) or in a similar clinical trial role.
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
  • Experience with electronic data capture (EDC) systems.
  • Strong organizational and time management skills.
  • Excellent written and verbal communication skills.
  • Ability to travel to clinical sites as required.
  • Proficiency in Microsoft Office Suite.
This opportunity is located in **Mumbai, Maharashtra, IN**, with a hybrid work model.
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate - Oncology Trials

160001 Chandigarh, Chandigarh ₹800000 Annually WhatJobs

Posted 19 days ago

Job Viewed

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Job Description

full-time
Our client, a prominent pharmaceutical company, is actively seeking a dedicated and experienced Clinical Research Associate (CRA) to join their team in Chandigarh, Chandigarh . This critical role involves overseeing and managing clinical trials, ensuring compliance with regulatory standards and protocols, and contributing to the development of life-saving oncology treatments. The successful candidate will work closely with investigators, site staff, and internal study teams to guarantee the integrity and quality of trial data. This is an office-based position that requires a strong understanding of clinical trial processes and a passion for advancing cancer research.

Key Responsibilities:
  • Conduct site initiation, monitoring, and close-out visits for clinical trials according to study protocols and Standard Operating Procedures (SOPs).
  • Ensure adherence to Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols.
  • Verify the accuracy, completeness, and integrity of clinical data through source document verification.
  • Manage investigational product accountability and ensure proper storage and handling.
  • Train and support site personnel on study-specific procedures, regulatory requirements, and data collection.
  • Identify and report adverse events and serious adverse events promptly according to protocol and regulatory guidelines.
  • Communicate effectively with investigators, study coordinators, and other site personnel to resolve data discrepancies and address protocol deviations.
  • Prepare and submit monitoring reports and follow up on action items identified during site visits.
  • Ensure timely collection of essential documents and regulatory binders.
  • Collaborate with internal study teams, including project managers, data managers, and medical monitors.
  • Participate in investigator meetings and training sessions.
  • Contribute to the continuous improvement of clinical trial processes and quality standards.
Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Minimum of 3 years of experience as a Clinical Research Associate, with a significant focus on oncology trials.
  • In-depth knowledge of GCP, ICH guidelines, and local regulatory requirements.
  • Proven ability to conduct site monitoring visits effectively and efficiently.
  • Excellent understanding of clinical trial procedures, including informed consent, data collection, and adverse event reporting.
  • Strong analytical, problem-solving, and critical-thinking skills.
  • Exceptional attention to detail and organizational skills.
  • Excellent written and verbal communication skills, with the ability to build rapport with site staff.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to travel to clinical trial sites as required (approximately 50-70% travel).
  • A proactive and results-oriented approach to work.
This is a rewarding opportunity to make a tangible difference in the lives of patients by advancing critical oncology research.
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate - Oncology Trials

462001 Indore, Madhya Pradesh ₹80000 Annually WhatJobs

Posted 19 days ago

Job Viewed

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Job Description

full-time
Our client, a leader in pharmaceutical innovation, is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their fully remote team. This role is pivotal in ensuring the successful execution of oncology clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. The CRA will be responsible for monitoring clinical trial sites, ensuring data accuracy and integrity, and verifying patient safety throughout the trial duration. The ideal candidate will possess a strong background in clinical research, a meticulous attention to detail, and exceptional communication skills, enabling effective collaboration with investigators, site staff, and internal stakeholders. This remote position offers the flexibility to manage your work from anywhere while contributing to groundbreaking medical advancements.

Key Responsibilities:
  • Conduct site qualification, initiation, monitoring, and close-out visits in accordance with protocol and regulatory requirements.
  • Ensure adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and study protocols.
  • Verify the accuracy, completeness, and integrity of clinical data collected at study sites.
  • Monitor patient safety and report adverse events as per regulatory guidelines.
  • Train and support site personnel on study procedures and documentation.
  • Maintain effective communication with investigators, study coordinators, and other site staff.
  • Prepare and submit site monitoring reports in a timely manner.
  • Manage investigational product accountability at study sites.
  • Ensure timely resolution of data queries and action items identified during monitoring visits.
  • Stay updated on relevant therapeutic areas, drug development processes, and regulatory guidelines.

Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree is a plus.
  • Minimum of 3-5 years of experience as a Clinical Research Associate.
  • Thorough understanding of GCP, ICH guidelines, and FDA regulations.
  • Experience in monitoring oncology clinical trials is highly preferred.
  • Excellent written and verbal communication skills.
  • Strong organizational and time management abilities.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to travel to sites as needed (though the role is primarily remote).
  • Detail-oriented with a strong commitment to quality and patient safety.
  • Self-motivated and able to work independently in a remote setting.

This is a challenging yet rewarding opportunity to contribute significantly to the development of life-saving cancer treatments from a remote location.
This advertiser has chosen not to accept applicants from your region.
 

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