Clinical Project Manager, 100%
As the main R&D work is being wrapped up, my client in Zurich is in need of a Clinical Project Manager to support outsourced studies on a global level. We are preferring candidates who have experience with infectious diseases/vaccine development and dealing in Phase I & II studies.
Key Responsibilities:
1. Leading and managing clinical trials to ensure adherence to scope, quality, budget, timelines and performing regular risk assessments.
2. Designing regulatory strategy, clinical trial design and development plans with support from the Clinical Director.
3. Analyzing, interpreting and presenting clinical data internally and externally. Discussing key findings with statisticians and conducting data checks, data queries and database integrity assignments.
4. Managing and preparing ethical and regulatory submissions.
5. Identifying, coordinating and supporting the development of clinical assays with external partners and/or clinical sites. Keeping samples’ database and shipments tracking.
6. Preparation and/or review of clinical study documentation (protocol, study plans and clinical study report).
7. Identifying, selecting, managing and overseeing external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories etc. to ensure performance and deliverables.
8. Authoring, revising and/or updating SOPs, Work Instructions and other relevant documents.
You are an efficient and enthusiastic team player with:
1. Hands-on experience in successfully managing all operational aspects of clinical trials.
2. Experience in the development of study-related documents like study protocols, interim reports, final study reports, etc.
3. Experience in management of CROs, vendors and consultants.
4. Good understanding of the study application packages and the communication with ECs, IRBs and regulatory authorities like EMA, FDA, etc.
5. In-depth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans.
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