Senior Director Clinical Data Management

3 hours ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Job Title: Senior Director, Clinical Data Management

Join Sun Pharmaceutical Industries, Inc. as a Senior Director, Clinical Data Management, and lead the Clinical Data Management (CDM) function within Research and Development (R&D) Department. As a key member of the R&D team, you will be responsible for effective leadership, planning, and oversight of the CDM function, ensuring rigorous collection and analysis of data.

Key Responsibilities:

  • Provide 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 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.

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.

Work Environment:

Corporate office environment.

Travel Estimate:

Up to 20%.

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