Job Detail

JOB DESCRIPTION

Job Description

As an addition to our Global Clinical Trial Operations Team, we are looking for a Clinical Research Manager (CRM) (m/f/d).

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, our 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.

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.

The primary activities include but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT)


• Responsibility for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out


• Accountability for performance for assigned protocols in Switzerland in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally


• Reviewing of Monitoring Visits Reports and escalation of performance issues and training-needs to the line manager


• Performing of Quality control visits as required


• Leading of local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration


• Responsible for creating and executing a local risk management plan for assigned studies


• Ensuring compliance with CTMS, eTMF and other key systems in assigned studies


• Escalates as needed different challenges and issues to CRD/CQM and or CTT (as appropriate)


• Responsible for the collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies


• Country Main Point of Contact for programmatically outsourced trials for assigned protocols


• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)


• Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed


• As a customer-facing role, this position will build business relationships and represent our company with investigators


• Shares protocol-specific information and best practices across countries\clusters

Qualifications:

• Bachelor’s Degree in Science, Biology or equivalent. An advanced degree would be advantageous (e.g., Master’s degree, MD, PhD)


• Minimum of 8 years’ experience in clinical research


• Minimum of 5 years` CRA experience is necessary


• A very deep knowledge of the local regulatory environment, as well as scientific and clinical research knowledge, is required


• Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously


• Excellent German and English communication skills (verbal and written) and effective communication skills, including the ability to build a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.


•  Experience in Project Management for at least 2 years


• Strong organizational skills with demonstrated success required


• We are looking for a strategic thinker, who has the ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the CRD


• Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery


• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption


• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders


• Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical


• Ability to travel domestically and internationally approximately 40% of working time

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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 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 (Weystrasse, 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.  

The Swiss subsidiary is based in Lucerne's city center and is home to the human medicine organization.  Various departments are located here, including oncology, vaccines, hospital care, primary care, women's health as well as other fields such as clinical research, regulatory affairs, market access, medical affairs and policy & communications.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, ImpactingLives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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 Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

50%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

2

Requisition ID:R57688