Sr. Director, Clinical Data Management
Company: Sun Pharmaceutical Industries, Inc.
Location: Princeton
Posted on: October 15, 2024
Job Description:
Job Title:Head of Clinical Data ManagementJob
Grade:G6/G7Department:Biostatistics and Data ManagementFLSA
Classification: -Manager's Job Title:Head of BDMDepartment Head
Title:Associate VPDoes This Position Have Any Direct Reports?YesJob
Description Approval Date: - - - - -Job SummaryThis 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
environmentPhysical Requirements:NATravel EstimateUp 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). -
Keywords: Sun Pharmaceutical Industries, Inc., Vineland , Sr. Director, Clinical Data Management, Executive , Princeton, New Jersey
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