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Senior Director, Clinical Data Management

2 months ago

Princeton, United States Sun Pharmaceutical Industries, Inc. Full time

Job Title:

Head of Clinical Data Management

Job Grade:

G6/G7

Department:

Biostatistics and Data Management

FLSA Classification:

Manager's Job Title:

Head of BDM

Department Head Title:

Associate VP

Does This Position Have Any Direct Reports?

Yes

Job Description Approval Date:

Job Summary

This position reports to Head of Biostatistics and Data Management (BDM) within Research and Development (R&D) Department at SPARC. Main responsibilities will 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. Additionally, 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.

Area Of Responsibility

  • 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 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.

Work Conditions:

Corporate office environment

Physical Requirements:

NA

Travel Estimate

Up to 20%

Education and Job Qualification

  • 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

  • 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).