Work Experience: 3+ Years
Work location: Kochi/Kolkata
Work Mode: Hybrid/Homebased
Shift Timings: 5:00 am -2:00 pm / 2:00 pm 11:00 pm
Must Have Skills: Rave, clinical data management, Hands on experience in conduct, close out and start up process.
Job Overview:
Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
Job Responsibility:
- Serve as a Data Operations Coordinator (DOC) for one protocol involving fewer than five operational staff members (excluding Data Entry personnel), or for 15+ easy to moderately complex central laboratory studies. May also serve in a supporting leadership capacity for specific data management functions (e.g., coding, testing, or database design for technologies not requiring advanced programming), with appropriate guidance.
- Provide backup support to a DOC or Data Team Lead (DTL) as required.
- Participate in clinical data review activities to ensure accuracy, completeness, and adherence to protocol requirements.
- Prepare, document, and resolve data clarification forms and queries as needed.
- Lead database audit activities, ensuring that all processes are conducted in accordance with organizational quality standards.
- Contribute to the development, testing, and validation of study databases and edit check specifications.
- Perform programming-related testing tasks to support database and system validation.
- Execute clinical data coding activities in alignment with project standards and coding guidelines.
- Ensure thorough understanding of and compliance with all core operating procedures, standard working instructions, and applicable quality requirements.
- Achieve assigned project objectives within defined timelines and quality expectations.
- Foster and maintain effective communication and collaboration with the Clinical Data Management (CDM) team and other crossfunctional stakeholders.
Educational Qualification: Bachelor's Degree Clinical, biological or mathematical sciences, or related field required
