Beschreibung
CTL II / Clinical Trial Leader (m/f/d)
Reference: -en
Start: asap
Duration: 18 MM++
Main tasks:
- Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country trials.
- Responsible for leading and matrix managing (NO direct reports) 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 scientific review of the clinical trial data (as needed)
- Coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations
- 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
Main qualifications
- BSc or MSc in life sciences or nursing, PhD level scientist with life sciences background, PharmD or equivalent qualification or work experience
- Relevant experience 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 language skills
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Zlatan Mujagic
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