1. Serve as Project Data Manager for multiple projects/trials from multiple business units (BUs) and providing professional Data Management input to Clinical Trial Teams (CTTs).
2. Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to CROs as needed.
3. Provide CDM input to study protocols and Study Specification Worksheets (SSW) for CRO proposal requests; audit/qualify CROs at India and provide input on CRO selection.
4. Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Validation and Analysis Plans (VAPs) as appropriate.
5. Ensure complete and consistent medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and drug safety databases.
6. Monitor clinical data quality and progress of trials outsourced to international CROs; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable.
7. Proactively identify project threats and resolve issues with clinical trial teams; escalate to US Biometrics management if necessary and appropriate.
8. Ensure up-to-date and accurate tracking of report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases.
9. Ensure timely completion of data management archiving; as necessary, respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues.
10. Provide input, review, and maintenance of local working practices and standards.
11. Contribute to the development of a Data Management organization through his/her leadership role within the DM Group for US Medical in India.
12. Lead and support clinical & non-clinical special projects.
13. May deputize for Head of Statistical Sciences Group for US Medical in India and assist in hiring, coaching, training, and mentoring of other Data Management staff.