Clinical Project Manager (remote-based)
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Hobson Prior are working with a leading clinical-stage organisation who are looking for a Clinical Project Manager to join them remotely on a contract basis. This position will lead the organisation's clinical operations as they move forward into the next stage of development.
- You will play a leadership role in managing multiple clinical trials, Phase I and beyond, across all functional areas of the drug development.
- Lead in the selection of CROs and review study feasibility assessments and project plans provided by the CROs.
- Provide strategic inputs including assessing operational feasibility, forecasting timelines, resources and budgets, and defining the vendor outsourcing strategy for assigned programs.
- Oversee CROs and provide timely input to ensure the study is executed according to the agreed project plan. Ensure accurate tracking and reporting of study metrics.
- Prepare and track required documentation from clinical sites.
- Oversee clinical trials operations to ensure compliance with quality measures including the FDA regulations and current ICH GCP guidelines.
- Effectively identify, communicate and mitigate program status, risks, and changes that may impact quality, timelines, and cost.
- Accountable for ongoing review of all study documents (IB, protocol amendments, reports, etc.), informed consents, case report forms, adverse event narratives, study materials and monitoring tools, as requested.
- Continuously review data from the clinical trial database to identify abnormal results, assess clinical significance, identify any efficacy and/or safety trends and determine if a specific action is necessary.
- Excellent leadership skills coupled with goal-oriented personality.
- Self-motivated team player and able to work independently in a multidisciplinary team of biologists, chemists, clinical partners and external collaborators in a dynamic environment.
- A strong sense of urgency, decisiveness and accountability, and experience working with aggressive timelines.
- An advanced degree in medical, medical-related, or appropriate biological sciences.
- A minimum of 3 years leadership experience within the pharmaceutical clinical research and operations.
- A broad knowledge of safety reporting principles, including FDA safety reporting regulations.
- Able to perform critical review of various medical, clinical, regulatory and safety documents.
- A proven track record in design and execution of clinical trials in multiple geographic jurisdictions, particularly the FDA.
- Outstanding presentation and communication skills (oral & written).
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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