Program Manager

We are seeking an experienced Program Data Manager to lead and oversee complex clinical data management projects and multiple clinical studies. This individual will provide strategic and operational leadership, coordinate global cross-functional teams, and ensure successful execution of clinical data management activities in alignment with organizational standards and regulatory expectations.

The ideal candidate will bring strong clinical data management expertise, program leadership capabilities, and experience managing multiple studies and stakeholders in a global clinical research environment.

Location: Durham, NC 27709

Work Arrangement: 100% Onsite

Duration: 12 Month Contract

Pay Rate: $55- $60/hr on W2

Key Responsibilities

• Lead and oversee multiple clinical studies and complex data management projects simultaneously.
• Manage project scope, milestones, timelines, risks, and deliverables to ensure successful project execution.
• Coordinate and influence global cross-functional teams and stakeholders across multiple functional areas.
• Develop and deliver operational and therapeutic-area training for internal and external study team members.
• Serve as a subject matter expert in clinical data management processes and functional operations.
• Act as the primary point of contact for Health Authority submission-related activities, including preparation of briefing books and participation in regulatory meetings as needed.
• Support the development of clinical data collection strategies in accordance with organizational standards.
• Apply knowledge of CDISC standards, including SDTM, to support clinical data collection and management activities.
• Provide guidance, mentorship, and best-practice recommendations to project teams.
• Represent CDM line management when required.
• Work independently with minimal supervision while providing senior-level guidance across teams and projects.
  
  
  

Required Qualifications

• Strong experience in Clinical Data Management within the pharmaceutical, biotechnology, CRO, or clinical research industry.
• Demonstrated experience managing complex clinical studies, programs, or multiple data management workstreams.
• Strong knowledge of clinical data management processes and clinical trial operations.
• Working knowledge of CDISC standards, particularly SDTM.
• Experience coordinating global and cross-functional teams.
• Experience with project planning, milestone management, risk assessment, and deliverable tracking.
• Exposure to Health Authority submissions and regulatory documentation.
• Excellent stakeholder management, communication, leadership, and problem-solving skills.
  
  
  

Preferred Qualifications

• Experience developing clinical data collection strategies.
• Experience delivering training to internal and external study teams.
• Previous experience serving as a senior subject matter expert or mentor.
• Experience representing clinical data management leadership in cross-functional environments.
  
  
  

Interested candidates are encouraged to apply with their updated resume.