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 prefererring candidates who has experience with infectious diseases / vaccine development and dealing in Phase I & II studies.
Key Responsibillities :
- Leading and managing clinical trials to ensure adherence to scope, quality, budget, timelines and performing regular risk assessments
- Designing regulatory strategy, clinical trial design and development plans with support from the Clinical Director
- Analyzing, interpreting and presenting clinical data internally and externally. Discussing key findings with statisticians and conducting data checks, data queries and database integrity assignments
- Managing and preparing ethical and regulatory submissions
- Identifying, coordinating and supporting the development of clinical assays with external partners and / or clinical sites.
Keeping samples’ database and shipments tracking
- Preparation and / or review of clinical study documentation (protocol, study plans and clinical study report)
- Identifying, selecting, managing and overseeing external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories etc.
to ensure performance and deliverables
Authoring, revising and / or updating 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
- 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
12 hours ago