What are the responsibilities and job description for the Clinical Supplies Project Manager position at Collabera?
The Clinical Project Manager II will play a pivotal role in Clinical Supplies Project Management (CSPM) group within Clinical Drug Supply Management. This position ensures that investigational drugs are delivered to the right patient at the right time by managing clinical supply activities, overseeing long-term packaging runs, developing and modifying drug supply forecasts, and collaborating with cross-functional teams. The role supports global clinical trials across all phases (Phase I-IV) and therapeutic areas.
Key Responsibilities:
1. Protocol Review & Optimization:
- Review and refine the drug supply section in clinical protocols developed by medical writers.
- Collaborate with regulatory teams to address study-specific requirements (e.g., global vs. regional trials).
2. Forecasting & Planning:
- Develop and manage drug supply forecasts, ensuring real-time adjustments as trial timelines change.
- Plan and schedule initial and subsequent packaging runs in collaboration with internal operations.
3. Cross-Functional Collaboration:
- Partner with drug supply managers, labeling teams, quality assurance, logistics, and IRT teams to ensure seamless clinical supply operations.
- Ensure compliance with GXP standards and global regulatory requirements.
4. Technology & Tools Utilization:
- Utilize forecasting tools and IRT systems to manage clinical trial supplies dynamically.
- Apply Excel or other relevant tools for supply planning in the absence of specific forecasting systems.
5. Training & Development:
- Engage in industry-leading training programs to gain expertise in internal processes and systems.
Preferred Candidate Profile:
Experience & Expertise:
- Minimum 5 years of experience in Clinical Supplies Project Management (preferred).
- Familiarity with global regulatory standards (e.g., FDA, EMA) and international clinical trial logistics.
- Experience with Interactive Response Technology (IRT) systems is beneficial but not mandatory.
Salary : $60 - $70
