For one of our biggest clients, I am looking for a Clinical Project Manager. The role is part of the Vendor and Third-Party Management team.
Main Activities and Key Responsibilities:
1. Act as the main support for Vendor and Third-Party Management.
2. Coordinate activities and responsibilities with Evidence Generation study teams (Study Execution + Evidence Generation).
3. Serve as a central point of coordination with Evidence Generation teams.
4. Oversee the end-to-end process, including liaison with Legal, qualification, RFP, contracting, and PO management.
5. Interface with stakeholders and relevant functions, providing inputs and updates as needed.
6. Manage qualification project timelines and proactively alert stakeholders to deviations or risks.
7. Coordinate the steps for third-party (vendors and non-vendors) due diligence and/or qualification activities as required.
8. Ensure oversight, completion, and management of third-party due diligence and qualification activities.
9. Provide support and contribute to the third-party Quality Risk Assessment activities (QRAs).
Background:
1. Clinical Trial/Medical Affairs experience in a pharmaceutical company or a contract research organization is required.
2. Project management experience in clinical operations in a pharmaceutical company or a contract research organization.
3. Good knowledge of the regulatory requirements in Clinical Research and drug development.
4. Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
5. A broad understanding of main Health Authorities standards (e.g., FDA, EMEA) and ICH regulations and guidelines.
6. Understanding of procurement processes and knowledge of clinical external suppliers landscape (CROs, Central Labs, specialty services, eCOA, and new technologies).
7. Good understanding of clinical data systems/platforms and overall integration of clinical data system and processes.
Due to a high number of applicants, we can't go back to everyone; we will shortlist the most suitable candidates.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science and Project Management
Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Medical Practices
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