Clinical Data Management Director
20 hours ago
Job Grade: G6/G7
Department: Biostatistics and Data Management
FLSA Classification: Manager's Job Title: Head of BDMDepartment Head Title: Associate VP
Does This Position Have Any Direct Reports? Yes
Job SummaryThis position reports to the Head of Biostatistics and Data Management (BDM) within Research and Development (R&D) Department at Sun Pharmaceutical Industries, Inc. The main responsibilities include effective leadership, planning, and oversight within the Clinical Data Management (CDM) function, as well as facilitating collaboration across all R&D functions to ensure rigorous collection and analysis of data.
Key Responsibilities- Provides specific functional expertise and leadership within CDM.
- 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 the 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.
Corporate office environment
Physical RequirementsNATravel EstimateUp to 20%
Education and Job QualificationA 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
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 RoleExperience 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
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