Program Manager, GCDS Job - United States
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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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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.
Education Minimum Requirement:
- B.A. or B.S. degree, preferably in life sciences, computer science or related field
Required Experience and Skills:
- 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).
- Extensive program and/or project management experience managing and governing clinical information standards activities.
- Experience defining and implementing metadata driven processes for data collection, tabulation, analysis, and submission deliverable systems.
- 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.
- Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines.
- Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas.
- Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.
- Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in the management of multiple projects.
Preferred Experience and Skills:
- Knowledge of clinical data management systems (e.g., Inform, Rave).
- Knowledge of SAS and statistical methodologies.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Clinical Data Management
Job Title:Assoc. Dir, Clinical Data Mgmt
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd, NA-US-MA-Boston
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
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