Senior Director, Clinical Data Management

17 hours ago

MercervilleHamilton Square, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Job Title:

Head of Clinical Data Management

Job Summary:

This position reports to the Head of Biostatistics and Data Management within Research and Development 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.
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 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.
Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.

It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.

Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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