Global Clinical Trials Manager
vor 1 Tag
TN Switzerland is seeking a highly skilled Clinical Project Manager to support outsourced studies on a global level.
The ideal candidate will have experience with infectious diseases/vaccine development and dealing in Phase I & II studies.
Key Responsibilities:- Study Management: Leading and managing clinical trials to ensure adherence to scope, quality, budget, timelines, and performing regular risk assessments.
- Regulatory Strategy: Designing regulatory strategy, clinical trial design, and development plans with support from the Clinical Director.
- Data Analysis: Analyzing, interpreting, and presenting clinical data internally and externally. Discussing key findings with statisticians and conducting data checks, data queries, and database integrity assignments.
- Submissions: Managing and preparing ethical and regulatory submissions.
- Vendor Management: Identifying, coordinating, and supporting the development of clinical assays with external partners and/or clinical sites. Keeping samples' database and shipments tracking.
- Documentation: Preparation and/or review of clinical study documentation (protocol, study plans, and clinical study report).
- Vendor Oversight: Identifying, selecting, managing, and overseeing external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories, etc. to ensure performance and deliverables.
- SOP Development: Authoring, revising, and/or updating SOPs, Work Instructions, and other relevant documents.
You are an efficient and enthusiastic team player with:
- Operational Experience: Hands-on experience in successfully managing all operational aspects of clinical trials.
- Document Development: Experience in the development of study-related documents like study protocols, interim reports, final study reports, etc.
- CRO Management: Experience in management of CROs, vendors, and consultants.
- Regulatory Knowledge: Good understanding of the study application packages and the communication with ECs, IRBs, and regulatory authorities like EMA, FDA, etc.
- ICH-GCP Knowledge: In-depth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans.
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