Clinical Trial Coordinator

vor 1 Woche

Luzern, Luzern, Schweiz MSD Vollzeit

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.


In this position you are working for a leading biopharmaceutical company with a diversified portfolio of prescription medicines and vaccines.

The company has longstanding commitment to prevent and treat diseases and invests significantly in research and development to address unmet public health needs with innovative treatment options.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork.

As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


As an addition to our Global Clinical Trial Operations Team and based in Lucerne, we are looking for a Clinical Trial Coordinator (CTC) (permanent full-time contract).

As a Clinical Trial Coordinator you are responsible for comprehensive trial and site administration in Switzerland and in Austria. The person prepares, collates, distributes and archives clinical documents and ensures timely maintenance of tracking and reporting tools.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to ethics committees (ECs) and health authorities.

The CTC is collaborating at local level closely with the country operations manager (COM), the project manager (CRM) and the clinical research associate (CRA).

Furthermore, the CTC is managing payments according to contracts with clinical trial sites.

The primary activities include but are not limited to:


  • Trial and site administration:
  • Track (e.g. essential documents) and report (e.g. Safety Reports)
  • Ensure collation and distribution of study documents
  • Update databases and trackers
-
Document management:

  • Prepare documents and correspondence
  • Collate, distribute/ship, and archive clinical documents, e.g. eTMF
  • Prepare Investigator trial file binders
-
Regulatory & Site Start-Up responsibilities, collaborate with other country roles to:

  • Provide to and collect from investigators forms/lists for site start-up and submissions
  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for ECs and support health authority submissions.
-
Budgeting, Agreement and Payments, collaborate with finance/budgeting representatives for:

  • Calculate and execute payments to investigators
  • Control trial site payments against budget, track payments from site setup until closeout
  • Ensure adherence to financial and compliance procedures
-
Global trade compliance:

  • Check proforma invoices and customs declarations
  • Track import activities

Qualifications

  • Bachelor's or Master's Degree in Life Science, Biology or equivalent or completed job training in office management/administration/finance
  • Previous experience in clinical research or relevant healthcare experience
  • Good understanding of clinical research guidelines and the local regulatory environment
  • Fluent in German and English (verbal and written), Italian and/or French would be an asset.
  • Strong coordination, organizational, and time management skills.
  • High sense of accountability and urgency in order to properly prioritize and handle multiple tasks simultaneously in a changing environment
  • Ability to work effectively in office but also remote/virtual environment with a wide range of people
  • Positive mindset, growth mindset, work independently with assigned tasks
  • Proactive attitude to solving problems/proposing solutions


Your role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

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.


THE COMPANY


At our company, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world.

The company has had a presence in Switzerland since 1963 and employs around 1000 people at five sites in the cantons of Lucerne and Zurich.

We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" since 2012 showing the company's commitment to our employees and the community

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