Clinical Data Coordinator

Job Title: Data Coordinator, Clinical Data Management

Location - PAN INDIA

Experience - 5+ years

Key Accountabilities

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 the 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 the above activities performed by the CRO, as needed.
• Ensures compliance with own Learning Curricula, corporate and/or GxP requirements.
• Performs other duties as assigned.

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 Microsoft Office.

Behavioral Competencies

• Comfortable working in an ambiguous environment.
• Excellent teamwork, organizational, interpersonal, conflict resolution, and problem-solving skills.