Beschreibung
Clinical Trial Leader (m/f/d)
Reference: -en
Start: asap
Duration: 18 MM
Main tasks:
- 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 phase I/II studies (scientific and/or operational complexity) including multi-country / multi-center trials
- Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices. Communicate study progress to CTT, CS&I Management, TA Heads and project team members
- In collaboration with the Medical Expert and CTT, coordinate the ongoing medical / scientific review of the clinical trial data (as needed) coordinate the data analysis and interpretation including the development of first interpretable results
- Ensure a complete review is conducted of all study documentation within the as-signed studies / project at the end of each study, with all essential documents ap-propriately archived and Paper Trial Master Files physically transferred to the cen-tral 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/CTA(s), ensuring clear delegation / assignment of duties are documented
- Contribute to the identification and evaluation of clinical sites and external service providers as appropriate for assigned studies
- Provide advice to other departments and line functions and to cross-functional working groups as required as applicable to assigned studies
Main qualifications
- BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience
- Fluent in English
- Profound relevant experience in clinical trials / drug development (e.g. study management in a multinational environment using different models for trial execution)
Demonstrated leadership and problem-solving skills - Track record of successfully managing multiple, concurrent phase I and IIa complex clinical trials
- Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities
- Capable of clear written and verbal expression of ideas, an active/proactive communicato
- Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing a wide range of people building strong positive relationship
- High level of customer orientation awareness and focus
- Excellent organizational skills and interpersonal skills
- Used to and ability to work independently and in a team environment managing multiple priorities
- Being flexible and adapting in a changing environment
Main advantages:
- To work for and be a part of a big international pharmaceutical company
- To work in an multicultural environment
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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