Requisition ID: CLI007772
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125:year legacy. MSD's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Position Overview:
Under the direction of the applicable management, the Principal Clinical Data Manager (PCDM) is responsible and accountable, for ensuring quality and consistent end to end data management deliverables which can include trial and standards level data collection specification authoring. He/she is also accountable for providing comprehensive technical guidance and design specific recommendations to the Lead Clinical Data Managers (LCDMs) when appropriate. The PCDM is able to work independently or within a team or as a team leader with equal effectiveness. They will interact with staff across multiple MSD sites and serve in the role of mentoring, guiding, and providing project leadership for LCDMs as assigned.
Primary activities include, but are not limited to:
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All required activities outlined in the Lead Clinical Data Manager (LCDM) at the discretion and direction of management.
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Helps ensure quality and consistency of data management requirements, specifications and/or deliverables across trials and across therapy areas. This may include, but is not limited to:
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Data Collection and/or data validation specification authoring and/or consultation.
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End to end review of design/data validation specifications consistent with: Protocol requirements, Therapeutic Area (TA) needs and data requirements.
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Subject Matter Expert (SME) level peer review/quality checks of specification documents and other deliverables.
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Provides process and technical related recommendations and guidance to LCDMs.
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Supports LCDMs via consultancy and teaching by example and review as well as mentoring as needed.
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May be expected to partner with functional area representatives to ensure:
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appropriate use of database standards
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TA/program:level consistency related to database development specifications, data collection guidance and needs, and data validation requirements and tools, including external data in support of the GDO TA lead.
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Keeps abreast of end to end clinical data management processes, procedures, trends and regulations through interaction with stakeholders and experts both within and outside of MSD across the industry.
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Identifies and develops areas for improvement data management processes, standards and tools.
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May lead continuous improvement special projects, or any other data management tasks deemed appropriate by management.
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Primary leadership and oversight of all GDO Standards related roles, responsibilities and activities including but not limited to;
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GDMS Standards Review Committee representation and full engagement with GCDS
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GDO Standards Committee and GDO TAST Governance and Leadership, including quality, efficiency, effectiveness and resourcing
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GDO Standards Training Program development, implementation and Continuous maintenance
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Primary Standards SME for all GDO processes involving standards activities
Qualifications
Education: B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Experience:
At least 5 years' experience in Pharmaceutical Clinical Data Management.
Knowledge and Skills:
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Thorough knowledge of end to end clinical data management and clinical development process.
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Process oriented with QC/QA profile, technical expertise, standards, preferably with CDISC/SDTM knowledge.
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Demonstrated strong l
