Clinical Research Manager
Vor 2 Tagen
We 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.
As an addition to our Global Clinical Trial Operations Team and based in Lucerne (as well as home-office), we are looking for an Associate Director level **Clinical Research Manager (CRM)**.
As a Clinical Research Manager, you are accountable for the end-to-end performance and project management for assigned protocols in Switzerland in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the CRM could be responsible for several countries in a cluster.
**THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO**:
- Act as local project manager for assigned protocols, from study feasibility to close out, and key contact for headquarter study team
- Be accountable for performance for assigned protocols in a country in compliance with regulations, policies and procedures
- Lead local study teams to high performance; supports the Clinical Research Associates as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration and oversight
- Be responsible for creating and executing a local risk management plan for assigned studies
- Collaborates internally with Headquarter functions and locally with medical affairs and other departments to align on key decisions in his/her studies
- As this is a customer facing role, this position will build business relationships and represent our company with investigators
**Qualifications**:
- Proven CRA experience is necessary
- Solid Knowledge in Project Management in Clinical Research
- Strong organizational skills with demonstrated success required
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments
- Communicates effectively and builds a positive collaboration spirit in a remote/virtual environment and across countries, cultures and functions
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption
- Excellent German and English communication skills (verbal and written) and effective communication skills
- Ability to travel domestically and internationally approximately 40% of working time
**THE COMPANY**
Our 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, LUCERNE**
The 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
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