385 Clinical Data Manager jobs in India

I. Position Summary

The Senior Clinical Data Manager (CDM) is the Subject Matter Expert (SME) responsible for leading and executing all clinical data management activities from study startup through database lock. This role ensures all deliverables meet the highest standards of quality, are completed on time and within budget, and comply with all Standard Operating Procedures (SOPs), current industry, and regulatory guidelines (ICH, GCP, GCDMP). The CDM serves as the technical leader and primary contact for client and vendor communications.

II. Key Responsibilities

A. Study Leadership & Project Management

• Independently manage the end-to-end delivery of Data Management services for single and multi-service clinical trial projects.

• Serve as the primary liaison for internal teams, clients, and vendors, ensuring clear and effective communication throughout the study lifecycle.

• Guide and mentor junior members of the Data Management team, including supervising and scheduling Data Management Associates.

• Ensure data lock activities are performed according to agreed timelines, budget, and quality requirements.

B. Database Design & Setup (Design Phase Expertise)

• Serve as the technical expert for eCRF design, ensuring alignment with the study protocol and data management guidelines.

• Lead the execution of all study plans, from Data Management Plan (DMP) development through to database lock.

• Design, maintain, monitor, and lock databases for diverse trials, including Phase I (First-in-Human, PK/PD, SAD/MAD), Safety & Tolerability studies, utilizing various EDC systems.

• Apply in-depth knowledge of CDISC CDASH standards during database design and mapping.

C. Data Validation & Processing (Conduct Phase Expertise)

• Oversee all data entry, data cleaning, and data transfer activities.

• Implement and execute the Data Validation Plan (DVP) and create/maintain the Edit Check/Data Entry Guidelines (CCG/DEG) and Data Transfer Specifications (DTS).

• Develop and validate SAS programs for data validation, and the creation of CDISC SDTM, ADaM, and Define-XML datasets.

• Proactively identify and implement process improvements during study conduct (e.g., automating manual reconciliation processes like biomarker data checks) to improve efficiency and data quality.

D. Closeout & Submission Readiness

• Ensure all necessary activities are performed during the conduct phase to guarantee a smooth and timely database lock and closeout.

• Prepare and finalize data export files as required for statistical analysis and submission.

• Maintain audit-ready documentation and ensure complete traceability of all data management processes.

III. Required Qualifications & Skills

A. Experience

• Minimum of 5 years of progressive experience in Clinical Data Management, with demonstrated ability to independently manage entire studies.

• Proven experience working across all clinical trial phases, including Study Design, Conduct, and Closeout.

B. Technical Expertise

• Expert-level knowledge of all standard DM documents (DMP, DVP, CCG/DEG, DTS, Specs).

• In-depth working knowledge of major EDC systems and study building processes.

• Strong analytical, problem-solving, and technical skills in database programming (e.g., SQL, SAS).

• In-depth knowledge of CDISC CDASH standards and their practical application in eCRF design and database build.

• In-depth understanding of database structures.

C. Regulatory & Soft Skills

• In-depth knowledge of clinical trial processes, ICH, GCP, and GCDMP (SCDM) guidelines.

• Proven ability to provide leadership and think strategically to achieve business goals.

• Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines.

• Excellent written and verbal communication skills.

• Lead the planning, design, development, and validation of clinical trial databases (e.g., EDC systems).
• Develop and maintain Data Management Plans (DMPs) and Case Report Forms (CRFs) in compliance with regulatory guidelines (e.g., ICH GCP).
• Oversee data entry, data cleaning, and query resolution processes to ensure data quality.
• Manage data validation activities, including the development and execution of edit checks.
• Ensure timely database lock for clinical trial data.
• Collaborate closely with clinical operations, biostatistics, programming, and regulatory affairs teams.
• Provide technical guidance and mentorship to junior data managers and data management personnel.
• Participate in the selection and oversight of Contract Research Organizations (CROs) for data management activities.
• Develop and deliver training on data management processes and systems.
• Contribute to the continuous improvement of data management processes and SOPs.
• Ensure compliance with data privacy regulations (e.g., GDPR, HIPAA).
• Review and approve data management reports.
• Manage vendor relationships for data management systems and services.
• Contribute to the development and implementation of data standards (e.g., CDISC).
• Stay updated on industry best practices and regulatory requirements in clinical data management.

• Bachelor's or Master's degree in a scientific, healthcare, or related field.
• Minimum of 7 years of progressive experience in clinical data management within the pharmaceutical or biotech industry.
• Extensive experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
• Thorough understanding of ICH GCP guidelines and regulatory requirements for clinical trials.
• Proficiency in developing DMPs, CRFs, and data validation specifications.
• Strong knowledge of clinical trial processes and data lifecycle management.
• Experience with CDISC standards (SDTM, ADaM) is highly desirable.
• Excellent leadership, project management, and organizational skills.
• Strong analytical and problem-solving abilities with meticulous attention to detail.
• Effective communication and interpersonal skills for cross-functional collaboration.
• Ability to work independently and manage multiple projects simultaneously in a hybrid environment.
• Experience in mentoring or supervising data management teams is required.
• Familiarity with statistical software and programming concepts is a plus.

• Bachelor's degree in a life science, health science, computer science, or related field.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• In-depth knowledge of clinical trial processes, regulatory requirements (GCP, ICH guidelines), and data standards (CDISC).
• Hands-on experience with electronic data capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Veeva).
• Proficiency in developing data management plans, CRFs, and data validation specifications.
• Strong understanding of data cleaning, reconciliation, and database lock procedures.
• Excellent analytical and problem-solving skills.
• Superior attention to detail and accuracy.
• Effective written and verbal communication skills, particularly in a remote setting.
• Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines.
• Experience with SDTM and ADaM data standards is highly desirable.

• Lead the design and development of clinical databases (CRFs) using Electronic Data Capture (EDC) systems.
• Develop data management plans (DMPs), data validation plans (DVPs), and edit check specifications.
• Oversee the data cleaning process, including generating and resolving data queries.
• Ensure data consistency and integrity throughout the clinical trial lifecycle.
• Perform quality control checks on data management activities and deliverables.
• Coordinate with clinical operations, biostatistics, and programming teams to ensure timely data collection and database lock.
• Validate data outputs and reports for accuracy and completeness.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and other relevant regulatory requirements.
• Mentor and provide guidance to junior data management personnel.

• Bachelor's degree in a relevant scientific or healthcare field.
• Minimum of 5-7 years of experience in clinical data management within the pharmaceutical or biotech industry.
• Proficiency in multiple EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault EDC).
• Strong understanding of CDISC standards (SDTM, ADaM) and their implementation.
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Excellent analytical, problem-solving, and organizational skills.
• Detail-oriented with a commitment to data quality and accuracy.
• Effective communication and interpersonal skills for remote collaboration.
• Experience with database lock procedures and final data reporting is essential.

• Lead and manage clinical data management activities for assigned clinical trials, ensuring timely and high-quality data collection and database lock.
• Develop and review clinical data management plans (DMPs), data validation plans, and Case Report Forms (CRFs).
• Oversee the design, build, and testing of clinical databases using EDC systems.
• Define and implement data validation strategies, including query generation and resolution processes.
• Manage and mentor junior data managers and data management teams.
• Serve as the primary point of contact for data management issues with internal teams, investigators, and external vendors.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and other relevant regulatory requirements.
• Develop and maintain standard operating procedures (SOPs) and work instructions for data management activities.
• Contribute to the selection and implementation of clinical data management technologies.
• Participate in cross-functional team meetings and provide data management expertise.
• Perform quality control checks on data management deliverables.
• Analyze trends in data quality and identify areas for process improvement.
• Contribute to the training of clinical trial site staff on data entry and data management procedures.

• Bachelor's degree in a life science, computer science, or related field.
• Minimum of 6-8 years of progressive experience in clinical data management within the pharmaceutical or biotech industry.
• Proven experience in leading data management activities for global clinical trials.
• Expertise in Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Veeva EDC).
• Strong understanding of clinical trial lifecycle, database design, and data validation techniques.
• In-depth knowledge of GCP, ICH guidelines, CDISC standards (SDTM, CDASH).
• Excellent problem-solving, organizational, and project management skills.
• Proficiency in programming languages like SQL for data extraction and analysis is a plus.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote team environment.
• Detail-oriented with a commitment to data accuracy and integrity.

• Lead and mentor a team of clinical data managers, fostering a collaborative and high-performing remote work environment.
• Oversee the design, setup, validation, and maintenance of clinical databases (e.g., EDC systems).
• Develop and implement data management plans, data validation plans, and data transfer agreements.
• Ensure adherence to GCP, relevant regulatory guidelines (FDA, EMA), and company SOPs.
• Manage data cleaning activities, including query generation, resolution, and trend analysis.
• Oversee the creation and management of data dictionaries, edit checks, and data validation procedures.
• Collaborate with clinical operations, biostatistics, programming, and medical monitor teams to ensure timely and accurate data collection and reconciliation.
• Participate in the selection and implementation of new data management technologies and tools.
• Contribute to the development and continuous improvement of data management processes and best practices.
• Prepare metrics and reports on data management activities for project teams and senior management.
• Conduct user acceptance testing (UAT) for database builds and system updates.
• Ensure the timely delivery of quality clinical databases for study close-out and archival.

• Bachelor's degree in a scientific, technical, or healthcare-related field. Master's degree preferred.
• Minimum of 7 years of progressive experience in clinical data management within the pharmaceutical or biotech industry.
• Proven experience in leading and managing a data management team.
• Extensive experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Veeva Vault EDC).
• Thorough understanding of clinical trial phases, study designs, and regulatory requirements (GCP, ICH).
• Strong knowledge of database design, data standards (e.g., CDISC SDTM), and validation techniques.
• Exceptional problem-solving, analytical, and organizational skills.
• Excellent communication, interpersonal, and leadership abilities, particularly in a remote setting.
• Ability to manage multiple projects simultaneously and meet strict deadlines.