Clinical Project Manager
vor 4 Wochen
As a Clinical Project Manager at headcount AG, you will play a crucial role in supporting outsourced studies on a global level. We are seeking a candidate with experience in infectious diseases/vaccine development and dealing in Phase I & II studies.
Key Responsibilities:- Study Management: Lead and manage clinical trials to ensure adherence to scope, quality, budget, timelines, and perform regular risk assessments.
- Regulatory Strategy: Design regulatory strategy, clinical trial design, and development plans with support from the Clinical Director.
- Data Analysis: Analyze, interpret, and present clinical data internally and externally. Discuss key findings with statisticians and conduct data checks, data queries, and database integrity assignments.
- Regulatory Submissions: Manage and prepare ethical and regulatory submissions.
- Clinical Assays: Identify, coordinate, and support the development of clinical assays with external partners and/or clinical sites. Keep samples' database and shipments tracking.
- Study Documentation: Prepare and/or review clinical study documentation (protocol, study plans, and clinical study report).
- Vendor Management: Identify, select, manage, and oversee external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories, etc. to ensure performance and deliverables.
- SOPs and Work Instructions: Author, revise, and/or update SOPs, Work Instructions, and other relevant documents.
You are an efficient and enthusiastic team player with hands-on experience in successfully managing all operational aspects of clinical trials. You have experience in the development of study-related documents like study protocols, interim reports, final study reports, etc. You are familiar with the study application packages and the communication with ECs, IRBs, and regulatory authorities like EMA, FDA, etc. You have in-depth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans.
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Zürich, Zürich, Schweiz headcount AG VollzeitClinical Project ManagerHeadcount AG is seeking an experienced Clinical Project Manager to support outsourced studies on a global level. The ideal candidate will have a strong background in infectious diseases/vaccine development and experience with Phase I & II studies.Key Responsibilities:Study Management: Lead and manage clinical trials to ensure...
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