Senior Project Manager – Post Marketing Studies

Senior Project Manager:
Post Marketing Studies (12 month contract)

We are seeking a high-caliber Senior Project Manager to bridge the critical gap between clinical development and long-term patient access.

• Global Program Management:
  Lead the end-to-end setup, implementation, and oversight of Post-Trial Access (PTA), Expanded Access Programs (EAPs), and Named Patient Programs (NPPs).
• Study Oversight:
  Manage the operational delivery of Observational and Low-Interventional studies, ensuring data integrity and regulatory compliance.
• Investigator Initiated Trials (IITs):
  Act as the primary point of clinical oversight for IITs, ensuring alignment with company strategy and safety standards.
• Vendor & Budget Accountability:
  Drive full lifecycle management of external vendors and CROs. You will hold full accountability for program budgets, including forecasting, tracking, and reconciliation.
• Patient Continuity:
  Develop and execute strategies to ensure seamless drug access for patients following the completion of clinical trials across various global territories.

• Experience:
  
  3+ years of direct experience managing post-marketing studies, EAPs, or NPPs ina Biotech/pharma environment.
• Self-Starter Mindset:
  You are highly self-driven and comfortable operating with minimal oversight. You prefer building a path to waiting for one to be cleared.
• Technical Expertise: A deep understanding of the regulatory and logistical nuances of managed access and low-interventional study designs.
• Communication:
  Exceptional stakeholder management skills, with the ability to collaborate across Clinical, Medical Affairs, Supply Chain, and Quality functions.
• Resilience:
  You thrive in a lean, agile environment where adaptability is a core requirement for success.

Full time, onsite 3 days a week in Basel