TCS is hiring Clinical Data Coordinator Location – Mumbai/Pune/Bangalore Roles &

Responsibilities - Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes. These activities may include the following categories: Data Review - Performs data review of clinical trial data, including query management - Performs reconciliation review of external data against EDC data - May assist in creating study documents or assist in running study reports and metrics - Performs additional review activities for interim and final database locks as needed. Documentation & Filing - Files study documentation in electronic Trial Master File (eTMF) and department project files.

- Performs periodic quality review of eTMF documents.
- Assists with taking meeting minutes and documenting/tracking study data management activities.
- Performs data archival activities.
- Performs inspection readiness activities and supports CDM team during internal and regulatory inspections Data Collection Systems May support the set-up and testing of study data collection tools.

Additional

Activities - Assists with quality review of above activities performed by the CRO, as needed.





- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Performs other duties as assigned.

Educational

Qualifications - Associate or bachelor's Degree preferred Experience - Ideally 6 or more years relevant work experience, or equivalent combination of training and experience.

- Familiar with electronic data collection systems - Preferred knowledge of data management best practices & technologies as applied to clinical trials.
- Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

Special

Skills/Abilities - Robust attention to detail, and organizational skills - Good time management skills - Quick learner and comfortable learning new technologies and systems - Good knowledge of office software (Microsoft Office).

Behavioral

Competencies - Is comfortable with ambiguity.

- Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Job Complexity - Low-Medium complexity project.
- Occasional domestic/international travel to other sites, strategic partners, and therapeutic area events may be required.

Regards Manisha

Singh

📌 Clinical Data Management Associate (Mumbai)
🏢 Tata Consultancy Services
📍 Mumbai