Harsha Shekar
Associate Director, Clinical Data Management
- Role
- Associate Director Clinical Db Valiation at IQVIA
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Harsha Shekar
Summary: 14 years of experience in Clinical Data Management with overall 18+years of experience. Presently Working as a Senior Manager in IQVIA(Quintiles Research India Limited).Specialties: Project & People Management, Strong communication skill.Good Knowledge of electronic Data Capture, end to end knowledge of Data Management. Basic Knowledge of STDM.
Experience
Associate Director Clinical Db Valiation
Apr 2020 — Present
Handling a large team of Programmers and validation team members across different platforms.• Business owner on identifying and implementing unit level initiatives.• Leading and implementing Computer System Validation.• Maintain optimal utilization and project realization of revenue.• Managing the FSP program for large Customers.• Handling of Multiple customers for OC and Rave Projects.• Participate in the management meetings.• Set up goals for the team members; Perform mid-year and year-end reviews• Responsible for the programming and validation of all activities pertaining to Study start up.• Resource allocation for team members, develop and maintain timelines for all client deliverables.• Ensure the milestones are met with high quality for all the deliverables.• Provide hands on work support to the team members as needed.• Coordinate all stud start up activities with Data Management, Clinical Operations and SAS Programming teams.• Conducting timely Project Review Meeting (PRM) in order to handle the projects in an efficient manner.• Proactive risk management• Providing managerial support for the managers at project management, resource level.• Liaison with clients and internal stake holders in order to plan the projects in advance to ensure smooth delivery.• Supervising delivery management for EDC projects• Working in conjunction with different teams in order to meet the delivery targets
Education
APS College
BSC, PCM
1990 — 1993
Skills
- Standard Operating Procedure (Sop)
- Clinical Research
- CRO
- Management
- Good Clinical Practice (Gcp)
- Clinical Trials
- Gcp
- Databases
- Ich-Gcp
- 21 Cfr Part 11
- Clinical Data Management
- Pharmaceutical Industry
- Sop
- Data Management
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