Director, Clinical Data Management and Operations
4 days ago
Director, Clinical Data Management and Operations
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 Clinical Data Management tasks.
- Contributing to ensuring oversight of all outsourced Clinical Data Management 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 Biostatistics and Data Management on optimal resource utilization and capacity.
- Responsible for building capabilities and technical skills within the group to ensure effective delivery of Clinical Data Management services.
- Foster Collaboration within Biostatistics and Data Management 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.
Requirements:- 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 Clinical Data Management 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.
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Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timeJob Title:Senior Director, Clinical Data Management and OperationsJob 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 oversight within the Clinical Data Management function, ensuring the...
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Senior Director, Clinical Data Management and Operations
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Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timeJob SummaryThis 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...
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