Clinical Project Manager

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
Il y a 1 jour