CRA Manager (m/f/d)
Visualizza: 175
Giorno di aggiornamento: 25-03-2024
Categoria: R & D Scienza Lavoro duro e faticoso Salute / Assistenza medica Medical
Industria: Veterinary Services Biotechnology Research Pharmaceutical Manufacturing
Tipo di lavoro: Full-time
Contenuto del lavoro
Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.For our Swiss subsidiary in Global Human Health based in Lucerne, we are currently looking for a Clinical Research Associate Manager (CRA Manager). This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director, the person is responsible to manage a team of 10-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.The role will work with other local stakeholders e.g., Medical Affairs, Regulatory and PV to ensure alignment and development of the capabilities. The role will collaborate closely with the CRMs as well as the country Partner Line Managers to ensure alignment across all monitoring functions. The person contributes to capacity/resource planning activities to ensure efficient allocation of resources and work.The Primary Activities Include But Are Not Limited To- Manages the CRA team – career development, performance reviews, etc. and provides training, support and mentoring to the CRA to ensure continuous development
- Ensures CRA compliance to corporate policies, procedures and quality standards
- Provides input for capacity planning, to provide efficient use of resources
- Works with CRAs, CRMs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability
- Participates in or leads local / regional / global process and/or system improvement initiatives with focus on monitoring
- Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM and escalates site performance issues to CRM and CRD
- Bachelor’s degree in Science, preferably advanced degree with a strong emphasis in science and/or biology
- Strong experience within Clinical Research and experience as CRA monitoring clinical trials
- Line management experience preferred or at the minimum team leading experience with excellent people, time, and project management as well as organizational skills
- Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines
- Expertise in and excellent working knowledge of core trial management systems and tools
- Willingness to travel domestically and internationally up to 50% of working time
- Fluent in German and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
Scadenza: 09-05-2024
Clicca per candidarti per un candidato gratuito
Segnala lavoro
LAVORI SIMILI
-
⏰ 28-05-2024🌏 Genève, Genève GE
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
-
⏰ 28-05-2024🌏 Genève, Genève GE
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
-
⏰ 28-05-2024🌏 Muttenz, Basel-Landschaft BL
-
⏰ 28-05-2024🌏 Schlieren, Zürich ZH
-
⏰ 28-05-2024🌏 Sarnen, Obwalden OW
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH
-
⏰ 28-05-2024🌏 Zürich, Zürich ZH