Sr. Clinical Trial Coordinator

We are a leading biopharmaceutical company with a diversified portfolio of prescription medicines and vaccines. We have longstanding commitment to prevent and treat diseases and invests significantly in Research & 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 Senior Clinical Trial Coordinator - Administrator (SrCTC)(permanent full-time contract).

As a Senior Clinical Trial Coordinator - Administrator you are responsible for comprehensive trial and site administration in Switzerland and in Austria. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to ethics committees (ECs) and Swissmedic/AGES. The SrCTC is collaborating at local level closely with the country operations manager (COM), the project manager (CRM) and the clinical research associate (CRA). Furthermore, the SrCTC is managing payments according to contracts with clinical trial sites.

The person acts as process subject matter expert (SME), making recommendations for continuous improvements, providing training and mentoring to junior CTCs.

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 and tools
• Update databases and trackers

Document management:

• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Prepare Investigator trial file binders
• Obtain translations of documents

Regulatory & Site Start-Up responsibilities, collaborate with other country roles to:

• In a timely manner, 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 Swissmedic/AGES 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 set-up until close-out
• Ensure adherence to financial and compliance procedures

Quality & Oversight:

• Contribute strongly to CTC team knowledge by acting as process SME
• sharing best practices, making recommendations for continuous improvement and providing training
• Mentors junior CTCs

Global trade compliance:

• Check proforma invoices and customs declarations for all clinical supplies imported to Switzerland
• 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
• Minimum of 3 years’ 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 a big asset. Strong communication, negotiation and mentoring skills
• Strong coordination, organizational, and time management skills.
• Highly effective interpersonal skills and conflict management
• 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
• Ability to establish and maintain culturally sensitive working relationships
• Positive mindset, growth mindset, being self-driven, customer oriented
• Proactive attitude to solving problems/proposing solutions

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R147345