Clinical Trial Leader (100%) (897279-MST)
- Experience Level
- Senior Management
Our client a biopharmaceutical company is entering clinical trials. They are a steadily expanding and dynamic organization and are looking for a Clinical Trial Leader (CTL) who will help deliver new therapeutic breakthroughs for patients.
As Clinical Trial Leader you will lead the planning, implementation and execution of Clinical Trials to meet corporate and clinical research goals. The CTL is the lead scientist and primary clinical/scientific contact for the lead program and provides clinical, operational and project management expertise within the virtual, cross-functional team (including Preclinical, Data Management, Statistics, Drug Safety, Regulatory Affairs, Clinical Quality Assurance, and Translational Medicine).
- Lead clinical and operational activities across various functions to plan, implement and execute clinical program;
- Responsible for CRO management and oversight; ensure timelines and budget are met to achieve corporate milestones;
- Approve and track invoices received for all clinical activities;
- Proactively anticipate possible issues impacting the clinical trial conduct and help the organization to address them appropriately;
- Manage central TMF system;
- Monitor and review clinical data for integrity and completeness in ongoing studies;
- Act as the primary contact for vendors and help manage relations to third party providers;
- With CRO, ensure all documents are delivered on time to meet submission targets to Health Authorities and ECs;
- Oversee and manage drug supply logistics in collaboration with CMC to ensure adequate availability of drug material on site and compliant shipment is documented to cover all clinical activities;
- Support preparation of clinical study documents ensuring accuracy and completeness; review protocol, informed consents, study documents and ensure GCP compliance;
- Lead the development of clinical study reports, as needed.
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- MSc in life sciences or other equivalent degree in medical/biological sciences;
- 3 or more years experience within pharma clinical trial management/operations, coupled with a good knowledge of the drug development field;
- Experience in Oncology and Immunology (preferred);
- Thorough knowledge of GLP, GCP and ICH guidelines;
- Project management and budget management experience;
- Well-developed interpersonal skills. A track record of collaborating with and influencing a wide range of people, and of building positive relationships;
- Flexible mindset to thrive in a fast paced start-up environment. Eager to proactively learn, tackle issues and take accountability;
- Excellent oral communication and writing skills in English;
- Clear written and verbal expression of ideas; an active communicator.
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