Clinical Project Manager
vor 2 Monaten
Headcount 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 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.
- Process Development: Author, revise, and/or update SOPs, Work Instructions, and other relevant documents.
You will be an efficient and enthusiastic team player with:
- Hands-on experience in successfully managing all operational aspects of clinical trials.
- Experience in the development of study-related documents like study protocols, interim reports, final study reports, etc.
- Experience in management of CROs, vendors, and consultants.
- Good understanding of the study application packages and the communication with ECs, IRBs, and regulatory authorities like EMA, FDA, etc.
- 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 Manager Job DescriptionAs 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...
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