CRA Manager (m/f/d)

Job content

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

Qualifications

• 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

The CompanyOur company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.CITYBAY, LUCERNEThe Switzerland Head Office of our company’s Swiss Subsidiary is based in Lucerne’s city centre. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications.Who We Are …We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.What We Look For …Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee StatusRegularRelocationVISA SponsorshipTravel RequirementsFlexible Work ArrangementsShiftValid Driving LicenseHazardous Material(s)Requisition IDR250967