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Senior Director, Clinical Data Management
2 months ago
Senior Director, Clinical Data Management
Job Summary:This position reports to the Head of Biostatistics and Data Management within the Research and Development Department at Sun Pharmaceutical Industries, Inc. The successful candidate will provide leadership and guidance on managing and expanding in-house capabilities, overseeing CRO deliverables, development and implementation of departmental standards, applications, processes, and training, planning and allocating internal/external resources to ongoing and upcoming projects.
Key Responsibilities:- Provides specific functional expertise and leadership within Clinical Data Management.
- Responsible for the talent development, provides line management and supervision of team members in his/her group.
- Responsible for resource allocation across multiple therapeutic areas and projects ensuring effective delivery of project goals.
- Participating in the selection service providers for outsourcing of CDM tasks. Contributing to ensuring oversight of all outsourced CDM work to quality, budget and time.
- Participate in establishing and maintaining policies, standards and guidance affecting functional operational needs.
- Provides input to Head of BDM on optimal resource utilization and capacity.
- Responsible for building capabilities and technical skills within the group to ensure effective delivery of CDM services.
- Foster Collaboration within BDM with Biostatistics and with Statistical Programming to ensure efficiency and high quality of deliverables.
- Works collaboratively with clinical project managers, statistical programmers, clinical research associates, and others to meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting.
- Communicates effectively with internal team members, senior management, external experts and regulatory authorities.
- Authoring or directing input to key study-related documents produced by other functions.
- A Bachelor's degree in Science/Pharma/Technology Discipline with a minimum of 10 years of clinical data management experience in Pharma/Biotech industries.
- A minimum of 5 years leadership experience building and managing relevant functions in CDM Role.
- Experience in working with various eDC systems such as Oracle InForm, Medidata Rave etc. Proven ability of overseeing EDC build, UAT, data collection, data processing, coding, validations, database lock and directing a team of data managers working across multiple studies.
- Excellent problem solving skills.
Corporate office environment.
Travel Estimate:Up to 20%.
