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Project Development Manager
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Quality Project Manager
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Freelance Project Manager
Il y a 2 mois
Job Summary
Barrington James is seeking an experienced Freelance Clinical Project Manager to join a growing Biotech company in a remote role. The ideal candidate will have a strong understanding of clinical trial regulations and experience managing multiple Clinical Research Organizations (CROs) and vendors.
Key Responsibilities
- Take overall responsibility for Phase I-III clinical projects, ensuring alignment with established goals, objectives, and budget, in compliance with SOPs/GCP/ICH/regulatory requirements.
- Lead the cross-functional Trial Team (TTT) and manage day-to-day operations of the clinical study.
- Manage interactions with multiple CROs and clinical vendors/partners, coordinating clinical study timelines with Program Management to meet critical milestones.
- Proactively address issues that may jeopardize deliverables and resolve challenges during study conduct.
- Develop study plans and system set-up, perform country and site selection, and coordinate site management activities in collaboration with the team and CRO.
- Guide, author, audit, or edit study documents, including data reports, training materials, operational manuals, protocol development, Case Report Form (CRF), Informed Consent Form (ICF) design, and Clinical Study Report (CSR) writing.
- Facilitate the achievement of excellent data quality and oversee the trial budget.
Requirements
- Experience designing, running, and developing phase IIb clinical trials.
- Thorough understanding of the drug development process with a strong knowledge of ICH and GCP guidelines.
- Extensive knowledge of clinical trial regulations, including US FDA and EMA.
- Strong experience in the management of multiple CROs and other vendors.
- Influential and assertive communication skills (written and verbal).
- Proven project management abilities and study leadership.
- Ability to work independently and prioritize duties.
- Proactive team player, striving to find the best solutions in a collegial team environment.
- Fluent in written and spoken English and French.
