Team Lead - Clinical Data Management

Responsibilities:

1. Lead all data management aspects of a clinical study, starting from study set-up till close out.

2. Function as a single point of contact on multiple clinical trials involving client communications and collaboration with various stakeholders like Biostatistician, Programmers, Medical Monitors, Project Managers, Quality Control, Safety Managers, Third-Party Vendors, etc. to meet the project timelines.

3. Documentation of all clinical data management documents to match regulatory and SOP’s.

4. Direct communication with customer for data management timelines and work updates.

5. Maintain the data management study files in the audit ready condition.

6. Manage, monitor and allocate tasks to data operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.

7. Establish strong coordination with data operations team, functional leads, project managers and all other stake holders.

8. Serve as the escalation point for unresolved data issues or queries, work with client data managers, vendors and internal team members for resolution.

9. Ensure appropriate resources are assigned to meet project deliverables. 

10.Ensure service and quality meet agreed upon specifications as per the DMP and contract/SOW. 11.Implement quality management plans across multiple projects. Track service performance and provide leadership to identify root causes of issues and implement remedial actions.

12.Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organize and drive change.

13.Train and mentor data management and medical coding team in DM expertise.

14.Coordinate with third party vendors. E.g- CDMS, Medical dictionaries.

15.Ensure that data is reliable and valid so it can be used for analysis and regulatory submission.

16.Create and design Case Report Forms (CRF), design and test databases, integrate medical dictionaries, prepare edit checks, and perform User Acceptance Testing (UAT). Prepare documents like the Data Management Plan, CRF Completion Guidelines, and Data Validation plan.

17. Capture data, clean it, reconcile it, perform medical coding, and validate it. Regularly evaluate the data, which is called Interim Analysis.

18.Freeze and lock all clean data, which puts it into read-only mode. Lock the database and archive all documents. 

Education:

• A bachelor’s degree in life sciences, clinical research, pharmacy, or a related field.
• A master’s degree or relevant certifications (e.g., clinical research, PMP) would be an advantage. 

Experience:

08 Years

Skills:

MS-Office, Project Management, Clinical Data Management, Collaboration, Mentoring, Leadership, Interpersonal Communication, Quality Management, Risk Management.

Other requirements:

Technology- Leading CDMS software’s. Hard skills: Study Setup/Startup, Study Closeout, Clinical Trial Methodologies, Data Cleaning Methods, Specs Writing, Report Creations, Cdash, Cdisc, Medical Terminology/Coding, Lab/Vendor/Third Party Reconciliation, Query Management, Data Quality, Inspection/Audit, Drug Development.

CTC:

10-15 LPA