Program Manager, GCDS
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Program Manager oversees the cross-functional activities of the clinical information governance network in collaboration with the Director, Global Clinical Data Standards (GCDS). Responsible for ensuring a consistent project management methodology is applied to standards governance activities, including ensuring activities are chartered, resourced, tracked, and communicated in an effective and well-timed manner. Facilitates cross-functional standards governance meetings and ensures transparent issue tracking and timely resolution. Coordinates Merck’s standards governance network and facilitates Merck participating in and connecting with external standards related activities (e.g., CDISC, PhUSE, TransCelerate). Manages the definition, implementation, and maintenance of GCDS Standard Operating Procedures and supporting documentation to ensure compliance with worldwide regulatory and relevant internal Merck requirements.
Primary activities includes, but are not limited to:
- Lead cross-functional governance teams to manage the definition, management, use, and retirement of global and study-level clinical standards metadata based upon CDISC standards.
- Work with subject matter experts within the standards governance framework to ensure end-to-end, harmonized, data standards that incorporate Merck’s best practices and industry standards (e.g., CDISC), and facilitates the production of submission deliverables complaint with health authority regulations
- Lead/participate in cross-functional data governance reviews and projects.
- Lead/participate in departmental and/or cross-functional working groups and process improvement initiatives.
- Represents function in cross-functional project teams; establishes collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company.
- Maintain knowledge of new technologies, clinical information industry standards, regulatory requirements, and Merck guidelines and SOPs.
- Define and oversee implementation of a standards communication plan
- Define, implement, track and report on standards implementation metrics
- Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple Merck sites. Mentors, guides, and provides project leadership for junior staff as assigned.
- B.A. or B.S. degree, preferably in life sciences, computer science or related field
- Extensive program and/or project management experience managing and governing clinical information standards activities
- Exceptional communication skills (oral and written), with the ability to communicate with both technical and business subject matter experts
- Exceptional people and thought leadership skills; the ability to think strategically and to influence others
- Strong knowledge of the Drug Development Process, ICH and GCP guidelines
- A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.
- 15+ years work experience which includes 10 years of data management/statistical programming experience and a minimum 5 years in clinical data standards development; or advanced degree with 6+ years work experience of which 3 years need to be in clinical data standards development or metadata management
- In-depth, advanced knowledge of and direct experience implementing industry standards (e.g. Controlled Terminologies, CDISC CDASH, SDTM, ADaM, & HL7) and requirements for submission deliverables (e.g., SDRG, ADRG, Define.xml)
- Exposure to defining and implementing metadata driven processes for data collection, tabulation, analysis, and submission deliverable systems
- Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in the management of multiple projects.
- Project Management Certification
- Knowledge of clinical data management systems (e.g., Inform, Rave)
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Clinical Data Management
Employee Status: Regular
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Company Trade Name: Merck