Clinical Trial Leader
- Experience Level
- Senior Management
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a Clinical Trial Leader to be based in Basel for a 18-month contract position.
As a Clinical Trial Leader you are responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM), functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/SOPs) and procedures).
- Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be dependent on department workload and need).
- Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
- In collaboration with the Medical Expert and CTT, coordinate the ongoing medical / scientific review of the clinical trial data (as needed), and coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations. May support the Medical Expert on project documentation e.g. Briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.
- Ensure a complete review is conducted of all study documentation within the assigned studies / project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive
- Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions
- Oversee the work of assigned support CTL(s), ensuring clear delegation / assignment of duties are documented.
- Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies.
- Provide CS&I expert advice to other departments and line functions (e.g. CQA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.
- Maintenance of knowledge and training of ICH-GCP, current regulations and procedures.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
- Relevant experience (5+ years) in clinical trial management (e.g. study management in a multi-national environment using different models for trial execution).
- Demonstrated leadership and problem-solving skills.
- Track record of managing multiple, complex clinical trials.
- Capable of clear written and verbal expression of ideas, an active/proactive communicator.
- Ability to interact with a wide range of people and build strong positive relationships.
- Potential for customer orientation awareness and focus.
- Fluent written and oral English
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