MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-
year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD AG is a leading biopharmaceutical company with a diversified portfolio of prescription medicines, vaccines and animal health products.
MSD has longstanding commitment to prevent and treat infectious diseases and invests significantly in infectious disease R&D to address unmet public health needs with innovative treatment options.
MSD is recruiting for a Clinical Trial Coordinator (CTC) to be based in our office in Lucerne. In this role, the CTC is responsible for comprehensive trial and site administration.
Under the oversight of the Senior COM or COMs, the person prepares, collates, distributes and archives clinical documents.
The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB / ERC and Health Authorities.
The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance / budgeting representatives to manage CTRAs and payments.
Responsibilities 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 tools and documents
Update clinical trial databases (CTMS) and trackers
Clinical supply & non-clinical supply management, in collaboration with other country roles
Manage Labeling requirements and coordinate / sign translation change request
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
Update manuals / documents (e.g., patient diaries, instructions)
Document proper destruction of clinical supplies
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 evaluation / validation, site start-up and submissions
Obtain, track and update study insurance certificates
Support preparation of submission package for IRB / ERC and support regulatory agencies submissions
Publish study results for GCTO and RA where required per local legislation
Budgeting, Agreement and Payments :
Collaborate with finance / budgeting representatives for :
Develop, control, update and close-out country and site budgets (including Split site budget)
Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
Track and report contract negotiations
Update and maintain contract templates (in cooperation with Legal Department)
Calculate and execute payments (to investigators, vendors, grants)
Ensure adherence to financial and compliance procedures
Monitor and track adherence and disclosures
Maintain tracking tools
Meeting Planning :
Organize meetings (create & track study memos / letters / protocols)
Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Completed job training (office management, administration, finance, health care preferred) or B.A. / B.S. (Life Science preferred) or equivalent healthcare experience.
Minimum 1 - 2 years in Clinical Research or relevant healthcare experience
Fluent in German and business proficient in English (verbal and written) and excellent communication skills
Any additional local language like French or Italian is highly appreciated
Good understanding of Global, Country / Regional Clinical Research Guidelines and ability to work within these guidelines
Hands on knowledge of Good Documentation Practices
Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications.
Strong MS Excel skills required
ICH-GCP Knowledge appropriate to role
Excellent negotiation skills for CTCs in finance area
Behavioural Competency Expectations :
Effective time management, organizational and interpersonal skills, conflict management
Effective communication with external customers (e.g. sites and investigators)
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships
Demonstrates commitment to Customer focus, both internally and externally
Able to work independently
Proactive attitude to solving problems / proposing solutions
Your role at MSD 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.
At MSD, we’re inventing for life. MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity.
Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and / or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.
No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.