1,770 Clinical Data Manager jobs in India

Clinical Data Manager

Bengaluru, Karnataka ACL Digital

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

Experience: 5+ yrs

Work Mode: Work from Office

Work Location: Bangalore

LOOKING FOR IMMEDIATE JOINERS ONLY


Job Description - Clinical Data Manager :


OVERVIEW

The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.


KEY TASKS & RESPONSIBILITIES

• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.

• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.

• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.

• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.

• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.

• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.

• Perform Query Management

• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.

• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.

• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.

• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.

• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.

• Other duties as assigned.


CANDIDATE’S PROFILE:


Education & Experience

• 5+ years’ experience in Clinical Data Management preferred.

• Bachelor’s degree in a health-related field or equivalent experience preferred.

• CCDM Certification preferred.


Professional Skills

• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.

• Strong analytical and strategic thinking skills

• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.

• Excellent collaborative skills

• Demonstrated command of the English language with proficiency in both verbal and written communication


Technical Skills

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology

• Proficient with EDC and Clinical Data Management Systems

• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.

• Experience with RBQM methodology preferred.

• Exposure to CDISC guidelines and standards

This advertiser has chosen not to accept applicants from your region.

Clinical Data Manager

Bengaluru, Karnataka ACL Digital

Posted today

Job Viewed

Tap Again To Close

Job Description

Experience: 5+ yrs

Work Mode: Work from Office

Work Location: Bangalore

LOOKING FOR IMMEDIATE JOINERS ONLY

Job Description - Clinical Data Manager :

OVERVIEW

The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.

KEY TASKS & RESPONSIBILITIES

• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.

• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.

• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.

• Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies.

• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.

• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.

• Perform Query Management

• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities.

• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.

• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.

• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.

• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.

• Other duties as assigned.

CANDIDATE’S PROFILE:

Education & Experience

• 5+ years’ experience in Clinical Data Management preferred.

• Bachelor’s degree in a health-related field or equivalent experience preferred.

• CCDM Certification preferred.

Professional Skills

• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.

• Strong analytical and strategic thinking skills

• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.

• Excellent collaborative skills

• Demonstrated command of the English language with proficiency in both verbal and written communication

Technical Skills

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology

• Proficient with EDC and Clinical Data Management Systems

• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.

• Experience with RBQM methodology preferred.

• Exposure to CDISC guidelines and standards

This advertiser has chosen not to accept applicants from your region.

Clinical Data Manager

Chennai, Tamil Nadu Crescent Techservices

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Role : Associate Manager - Clinical Data Management
Location : Chennai, Tamil Nadu
Experience : 10+ Years

Requirements:
10-12 years of experience in clinical trial/data management and data operations.
Minimum 4-5 years of people management (preferred) experience with proven supervisory
skills.
Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
Strong background in EDC systems management and clinical data operations.
Experience in pharmaceutical, biotechnology, or CRO environment across multiple
therapeutic areas.
Technical Expertise
CTMS configuration and administration skills (Having knowledge in CRIO is an advantage).
Deep knowledge of EDC platforms and system integrations.
Strong understanding of regulatory requirements (HIPPA, FDA, EMA, ICH-GCP).
Experience with electronic systems validation and 21 CFR Part 11 compliance.
This advertiser has chosen not to accept applicants from your region.

Clinical Data Manager

Bengaluru, Karnataka ACL Digital

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

Experience: 5+ yrs
Work Mode: Work from Office
Work Location: Bangalore
LOOKING FOR IMMEDIATE JOINERS ONLY

Job Description - Clinical Data Manager :

OVERVIEW
The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.

KEY TASKS & RESPONSIBILITIES
• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.
• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.
• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.
• Perform Query Management
• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.
• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.
• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.
• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
• Other duties as assigned.

CANDIDATE’S PROFILE:

Education & Experience
• 5+ years’ experience in Clinical Data Management preferred.
• Bachelor’s degree in a health-related field or equivalent experience preferred.
• CCDM Certification preferred.

Professional Skills
• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.
• Strong analytical and strategic thinking skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.
• Excellent collaborative skills
• Demonstrated command of the English language with proficiency in both verbal and written communication

Technical Skills
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Proficient with EDC and Clinical Data Management Systems
• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.
• Experience with RBQM methodology preferred.
• Exposure to CDISC guidelines and standards
This advertiser has chosen not to accept applicants from your region.

Clinical Data Manager

Bengaluru, Karnataka ACL Digital

Posted today

Job Viewed

Tap Again To Close

Job Description

Experience: 5+ yrs

Work Mode: Work from Office

Work Location: Bangalore

LOOKING FOR IMMEDIATE JOINERS ONLY


Job Description - Clinical Data Manager :


OVERVIEW

The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.


KEY TASKS & RESPONSIBILITIES

• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.

• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.

• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.

• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.

• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.

• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.

• Perform Query Management

• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.

• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.

• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.

• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.

• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.

• Other duties as assigned.


CANDIDATE’S PROFILE:


Education & Experience

• 5+ years’ experience in Clinical Data Management preferred.

• Bachelor’s degree in a health-related field or equivalent experience preferred.

• CCDM Certification preferred.


Professional Skills

• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.

• Strong analytical and strategic thinking skills

• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.

• Excellent collaborative skills

• Demonstrated command of the English language with proficiency in both verbal and written communication


Technical Skills

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology

• Proficient with EDC and Clinical Data Management Systems

• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.

• Experience with RBQM methodology preferred.

• Exposure to CDISC guidelines and standards

This advertiser has chosen not to accept applicants from your region.

Clinical Data Manager

Bangalore, Karnataka ACL Digital

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Experience: 5+ yrs

Work Mode: Work from Office

Work Location: Bangalore

LOOKING FOR IMMEDIATE JOINERS ONLY


Job Description - Clinical Data Manager :


OVERVIEW

The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science.


KEY TASKS & RESPONSIBILITIES

• Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.

• Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.

• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.

• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.

• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.

• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.

• Perform Query Management

• Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.

• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.

• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.

• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.

• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.

• Other duties as assigned.


CANDIDATE’S PROFILE:


Education & Experience

• 5+ years’ experience in Clinical Data Management preferred.

• Bachelor’s degree in a health-related field or equivalent experience preferred.

• CCDM Certification preferred.


Professional Skills

• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems.

• Strong analytical and strategic thinking skills

• Detail oriented, ability to multitask with strong prioritization, planning and organization skills.

• Excellent collaborative skills

• Demonstrated command of the English language with proficiency in both verbal and written communication


Technical Skills

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology

• Proficient with EDC and Clinical Data Management Systems

• Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred.

• Experience with RBQM methodology preferred.

• Exposure to CDISC guidelines and standards

This advertiser has chosen not to accept applicants from your region.

Clinical Data Manager III/ Sr. Clinical Data Manager I (India)

Bengaluru, Karnataka Allucent

Posted today

Job Viewed

Tap Again To Close

Job Description

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Senior Clinical Data Manager I to join our A-team. The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.   This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings.

**This position is for the Bengaluru Location and not home-based**

In this role your key tasks will include:

  • Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites).  
  • Plan and project the resources required including management of tasks, timelines, risk and quality. 
  • Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition.
  • Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements.
  • Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements.
  • Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs). 
  • Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed.
  • Create training materials for EDC users and provide project-specific training as required. 
  • Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. 
  • Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock).
  • Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data.
  • Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance.
  • Organize and lead Quality Review activities during study.
  • Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA).
  • Manage the database maintenance, lock and close-out processes and procedure.
  • Participate in conference calls and/or meetings with vendors and sponsors.
  • Recognize and solve potential problems and evaluate effectiveness.
  • Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date. 
  • Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned.
  • Help to align data management and clinical programming best practices, standards and conventions within the company.
  • Provide leadership, expertise and support to other department members. 
  • Propose and support initiatives for improving efficiency.
  • Actively support to staff learning & development within the company.
  • Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions .
  • Represent the company at professional meetings, webinars or seminars.
  • Train and mentor data management staff, support in development of new training material and provide training to relevant staff.
  • Participate in the interview process for new recruits.
  • Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes.
  • Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System.
  • Assure good communication and relationships with (future) clients.
  • Contribute to and take part in client evaluations and visits.
  • Support in preparation of new proposals and budgets for Data Management services.

Requirements

To be successful you should possess:

  • Life science, healthcare degree and/or combination of education and experience.
  • Minimum 7 years of relevant work experience asa Clinical Data Manager.
  • Minimum 7 years of experience in drug development and/or clinical research.
  • Thorough knowledge and understanding of ICH-GCP,  21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements.
  • Good understanding of Medical Terminology.
  • Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA.
  • Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock).
  • Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation.
  • Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models.
  • Experience in developing data management standards.
  • Strong written and verbal communication skills including a good command of the English language.
  • Representative, outgoing and client-focused.
  • Ability to work in a fast-paced challenging environment of a growing company.
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
  • Administrative excellence. 
  • Attention to detail, strong technical, analytical and problem-solving skills.
  • Strong project management skills.
  • Ability to translate guidelines, rules and regulations in clear and usable recommendations.
  • Ability to simplify complex issues into understandable concepts.
  • Excellent organizational, negotiating and motivational skills.

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers :

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Clinical data manager Jobs in India !

Clinical Data Manager III/ Sr. Clinical Data Manager I (India)

Bengaluru, Karnataka Allucent

Posted today

Job Viewed

Tap Again To Close

Job Description

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Senior Clinical Data Manager I to join our A-team. The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. Position provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings.

**This position is for the Bengaluru Location and not home-based**

In this role your key tasks will include:

  • Lead and serve as primary contact for DM with all relevant parties both internally ( Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally ( sponsors, vendors (EDC, external data), and investigational sites).
  • Plan and project the resources required including management of tasks, timelines, risk and quality.
  • Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition.
  • Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements.
  • Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements.
  • Participate in the review of study documents ( protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs).
  • Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed.
  • Create training materials for EDC users and provide project-specific training as required. 
  • Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness. 
  • Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock).
  • Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data.
  • Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance.
  • Organize and lead Quality Review activities during study.
  • Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA).
  • Manage the database maintenance, lock and close-out processes and procedure.
  • Participate in conference calls and/or meetings with vendors and sponsors.
  • Recognize and solve potential problems and evaluate effectiveness.
  • Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date.
  • Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned.
  • Help to align data management and clinical programming best practices, standards and conventions within the company.
  • Provide leadership, expertise and support to other department members. 
  • Propose and support initiatives for improving efficiency.
  • Actively support to staff learning & development within the company.
  • Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions .
  • Represent the company at professional meetings, webinars or seminars.
  • Train and mentor data management staff, support in development of new training material and provide training to relevant staff.
  • Participate in the interview process for new recruits.
  • Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes.
  • Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System.
  • Assure good communication and relationships with (future) clients.
  • Contribute to and take part in client evaluations and visits.
  • Support in preparation of new proposals and budgets for Data Management services.
  • Requirements

    To be successful you should possess:

  • Life science, healthcare degree and/or combination of education and experience.
  • Minimum 7 years of relevant work experience asa Clinical Data Manager.
  • Minimum 7 years of experience in drug development and/or clinical research.
  • Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements.
  • Good understanding of Medical Terminology.
  • Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA.
  • Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock).
  • Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation.
  • Experienced in CDISC conventions, , CDASH, TAUG models and hands on experience implementing these models.
  • Experience in developing data management standards.
  • Strong written and verbal communication skills including a good command of the English language.
  • Representative, outgoing and client-focused.
  • Ability to work in a fast-paced challenging environment of a growing company.
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
  • Administrative excellence.
  • Attention to detail, strong technical, analytical and problem-solving skills.
  • Strong project management skills.
  • Ability to translate guidelines, rules and regulations in clear and usable recommendations.
  • Ability to simplify complex issues into understandable concepts.
  • Excellent organizational, negotiating and motivational skills.
  • Benefits

    Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
  • Disclaimers :

    “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

    This advertiser has chosen not to accept applicants from your region.

    Remote Clinical Data Manager

    570001 Mysore, Karnataka ₹65000 Annually WhatJobs

    Posted 3 days ago

    Job Viewed

    Tap Again To Close

    Job Description

    full-time
    Our client is actively seeking a detail-oriented and experienced Remote Clinical Data Manager to join their pharmaceutical research team. This is a fully remote position, enabling you to contribute from any location while being an integral part of our client's mission to advance healthcare. As a Clinical Data Manager, you will be responsible for the end-to-end management of clinical trial data, ensuring its accuracy, completeness, and integrity from study startup through database lock. Your primary duties will include developing Case Report Forms (CRFs), building clinical databases, implementing data validation checks, managing data cleaning processes, and performing data review activities. You will work closely with clinical operations, biostatistics, and programming teams to define data management standards and execute study-specific data management plans. The ideal candidate will have a strong understanding of clinical trial processes, EDC (Electronic Data Capture) systems, and data standards such as CDISC. Exceptional organizational skills, meticulous attention to detail, and proficiency in data analysis and quality control are essential. You must be adept at problem-solving, identifying data discrepancies, and implementing effective resolutions. The ability to work independently, manage multiple studies simultaneously, and communicate effectively with a diverse, remote team is crucial for success in this role. This opportunity offers the chance to be part of critical drug development projects and contribute significantly to patient safety and product efficacy.

    • Develop and manage clinical databases using EDC systems.
    • Design and implement Case Report Forms (CRFs) and eCRFs.
    • Develop and execute data management plans and data validation guidelines.
    • Perform data cleaning activities, query resolution, and data review.
    • Ensure data accuracy, completeness, and consistency according to protocol and regulatory requirements.
    • Collaborate with clinical teams, statisticians, and programmers.
    • Oversee data entry and data quality control processes.
    • Contribute to database lock activities.
    • Ensure compliance with CDISC standards and regulatory guidelines.
    Qualifications:
    • Bachelor's degree in a relevant scientific or healthcare field.
    • Minimum of 3-5 years of experience as a Clinical Data Manager in the pharmaceutical or CRO industry.
    • Proficiency with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm).
    • Solid understanding of clinical trial phases, data management principles, and regulatory requirements (GCP, ICH).
    • Familiarity with CDISC standards (SDTM, ADaM) is highly desirable.
    • Excellent analytical and problem-solving skills.
    • Strong communication and interpersonal skills, especially for remote collaboration.
    • Ability to manage multiple projects and meet strict deadlines.
    This advertiser has chosen not to accept applicants from your region.

    Clinical Data Manager III (India)

    Chennai, Tamil Nadu Allucent

    Posted today

    Job Viewed

    Tap Again To Close

    Job Description

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

    We are looking for Clinical Data Manager III (CDM III) to join our A-team. As CDM III at Allucent, you will manage and coordinate DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.

    PLEASE NOTE: This is not a remote position and we are looking for a candidate who can work from the office (Chennai Location).

    In this role your key tasks will include:

  • Lead and serve as primary contact for DM with all relevant parties both internally ( Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally ( sponsors, vendors (EDC, external data), and investigational sites)
  • Plan and project the resources required including management of tasks, timelines, risk and quality
  • Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests
  • Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements
  • Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements
  • Participate in the review of study documents ( protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs)
  • Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
  • Create training materials for EDC users and provide project-specific training as required
  • Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
  • Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) 
  • Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
  • Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance 
  • Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities
  • Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA) 
  • Manage the database maintenance, lock and close-out processes and procedure 
  • Participate in conference calls and/or meetings with vendors and sponsors 
  • Recognize and solve potential problems and evaluate effectiveness 
  • Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
  • Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned 
  • Help to align data management and clinical programming best practices, standards and conventions within the company 
  • Propose and support initiatives for improving efficiency.
  • Requirements

    To be successful you will possess:

  • Minimum Educational Requirement: Preferably Life science graduate or equivalent qualification
  • 6+ years’ experience in clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries
  • Proven knowledge of clinical data management processes and clinical database systems, including Electronic Data Capture applications.
  • Good communication skills written and verbal.
  • Effective working knowledge of Microsoft Office Suite including Word and Excel.
  • Demonstrated proactiveness, problem-solving, analytical, organizational and time management skills.
  • Demonstrated flexibility and ability to work well in a fast-paced growing organization.
  • Demonstrated ability to work in a global team environment.
  • Demonstrates a basic understanding of Clinical Trials and the flow of data.
  • Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs.
  • Comprehension of study documentation standards including Trial Master File organization and archival processes.
  • Familiarization of data standards, preferably CDISC STDM.
  • Benefits

    Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
  • “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

    This advertiser has chosen not to accept applicants from your region.
     

    Nearby Locations

    Other Jobs Near Me

    Industry

    1. request_quote Accounting
    2. work Administrative
    3. eco Agriculture Forestry
    4. smart_toy AI & Emerging Technologies
    5. school Apprenticeships & Trainee
    6. apartment Architecture
    7. palette Arts & Entertainment
    8. directions_car Automotive
    9. flight_takeoff Aviation
    10. account_balance Banking & Finance
    11. local_florist Beauty & Wellness
    12. restaurant Catering
    13. volunteer_activism Charity & Voluntary
    14. science Chemical Engineering
    15. child_friendly Childcare
    16. foundation Civil Engineering
    17. clean_hands Cleaning & Sanitation
    18. diversity_3 Community & Social Care
    19. construction Construction
    20. brush Creative & Digital
    21. currency_bitcoin Crypto & Blockchain
    22. support_agent Customer Service & Helpdesk
    23. medical_services Dental
    24. medical_services Driving & Transport
    25. medical_services E Commerce & Social Media
    26. school Education & Teaching
    27. electrical_services Electrical Engineering
    28. bolt Energy
    29. local_mall Fmcg
    30. gavel Government & Non Profit
    31. emoji_events Graduate
    32. health_and_safety Healthcare
    33. beach_access Hospitality & Tourism
    34. groups Human Resources
    35. precision_manufacturing Industrial Engineering
    36. security Information Security
    37. handyman Installation & Maintenance
    38. policy Insurance
    39. code IT & Software
    40. gavel Legal
    41. sports_soccer Leisure & Sports
    42. inventory_2 Logistics & Warehousing
    43. supervisor_account Management
    44. supervisor_account Management Consultancy
    45. supervisor_account Manufacturing & Production
    46. campaign Marketing
    47. build Mechanical Engineering
    48. perm_media Media & PR
    49. local_hospital Medical
    50. local_hospital Military & Public Safety
    51. local_hospital Mining
    52. medical_services Nursing
    53. local_gas_station Oil & Gas
    54. biotech Pharmaceutical
    55. checklist_rtl Project Management
    56. shopping_bag Purchasing
    57. home_work Real Estate
    58. person_search Recruitment Consultancy
    59. store Retail
    60. point_of_sale Sales
    61. science Scientific Research & Development
    62. wifi Telecoms
    63. psychology Therapy
    64. pets Veterinary
    View All Clinical Data Manager Jobs