at Merck in Dover, Delaware, United States
The Program Manager oversees the cross-functional activities of the clinical information governance network in collaboration with the Director, Global Clinical Data Standards. 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 our company’s standards governance network and facilitates our company 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 requirements.
+ 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 our company’s best practices and industry standards (e.g., CDISC), and facilitates the production of submission deliverables compliant 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 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 sites. Mentors, guides, and provides project leadership for junior staff as assigned.
Education Minimum Requirements
+ BA/BS; or Associates Degree with minimum of 8 years’ work experience.
**Required Experience and Sk
Dover, Delaware 19904