Program Manager

at Merck in Dover, Delaware, United States

Job Description

Job Description

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.

Primary Responsibilities

+ 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

Job Details




Dover, Delaware 19904
United States

Copy Link

Job Posting: JC186198478

Posted On: Jun 20, 2021

Updated On: Jun 27, 2021