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

📌 Clinical Data Coordinator Bengaluru
🏢 Siro Clinpharm
📍 Bengaluru