The Project Manager oversees the service delivery of clinical data flow components from data collection to downstream systems.  Responsible for ensuring a consistent project management methodology is applied to service delivery, including ensuring activities are resourced, tracked, and communicated in an effective and well-timed manner. Facilitates cross-functional service delivery meetings and ensures transparent issue tracking and timely resolution.

• Lead cross-functional teams to manage service delivery using global and study-level clinical standards defined using CDISC foundational standards.
• Work with subject matter experts within the standards governance framework to ensure comprehensive end-to-end metadata requirements to enhance the use of CDISC standards and facilitate the production of submission deliverables complaint with health authority regulations
• Be the liaison between the business and technical teams
• Manage resources and production of standards components necessary for successful service delivery and data flow to downstream systems
• Define, implement, track and report on service delivery metrics
• Analyze data collection design and recommend data flow components solutions based on understanding of relationships between data collection and downstream systems
• Report on common sources of technical issues or questions and make recommendations to subject matter experts within the standards governance framework
• Lead/participate in departmental, cross-functional initiatives data governance reviews, projects and process improvement activities.
• Maintain knowledge of new technologies, clinical information industry standards, regulatory requirements, and Merck guidelines and SOPs.
• Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple Merck sites.

Education Minimum Requirement:

B.A. or B.S. degree, preferably in life sciences, computer science or related field

Required Experience and Skills:

1. 8+ years’ work experience which includes 4 years of data management experience and a minimum of 2 years clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development
2. 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.
3. Advanced knowledge and leading-edge skills in clinical data standards (e.g., CDISC)
   • CDISC Study Data Tabulation Model (SDTM) expertise
4. Electronic Data Capture expertise (e.g. InForm)
5. Analysis and Reporting experience
6. Ability to effectively organize and manage multiple assignments with challenging timelines.
7. Experience in defining, implementing, and managing process improvement projects and documentation
8. Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines
9. Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas
10. Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects. 

Preferred Experience and Skills:

• Extensive program and/or project management experience managing and governing clinical information standards activities
• Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.
• In-depth 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)

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