Senior Clinical Data Coordinator (CDC)

Job Location: Remote working

Experience: 5+ years

Key Accountabilities

- 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 bachelors Degree preferred

Experience

- Ideally 5+ or more years relevant work experience, or equivalent combination of experience in Clinical Data Management.
- Strong hands-on with Veeva EDC (electronic data collection) systems
- Solid hands-on with Veeva CDMS
- Experience with UAT Systems tools
- 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

- Strong 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).

📌 Clinical Data Coordinator (Bengaluru)
🏢 Siro Clinpharm
📍 Bengaluru