Maynor Consulting, Reputed Pharmaceutical Company
Post: Clinical Data Manager-2
Job Description:
Key Responsibilities: Clinical Data Manager
Project and Line Management, Process excellence and supervision of all Data Management activities.
1. Actively contributing to the review of working practices and the development of SOPs
2. Coordinating with Data Management team to ensure timelines and quality for data deliverables by requesting and reviewing relevant metric reports and Sampling OC discrepancies and reviewing Data Clarification Form (DCF) generation, tracking and processing.
3. Develop and maintain good communications and working relationships with Data Management team and keep the team updated about issues and status of project
4. Handling AE/SAE reconciliation and External Data reconciliation.
5. Participating in OC database closeout planning and tracking. Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation before submitting to Biostatistics
6. Potentially serve as a reviewer of all project documents such as protocols, CRFs (or eCRFs and eDiary), CRF (eCRF) completion guidelines, DMP etc and also coordinate the review and approval of same
7. Reviewing and approving Data Management Plan components (Study Summary/Data Flow Diagrams, Timelines, Critical Variables list, etc) in coordination with Biometrics and Project manager
8. Support the training of project staff on project-specific, global, standardized data management processes and also identify training needs.
9. Other Data Management related task assigned by line management.
Additional Information:
Experience: 10 years
Location: Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 24th June, 2013
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