Job Description
Responsibilities include, but are not limited to:
o Track (e.g. essential documents) and report (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management, in collaboration with other country roles
o Manage Labeling requirements and coordinate/sign translation change request
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents, e.g. eTMF
o Assist with eTMF reconciliation
o Execute eTMF Quality Control Plan
o Update manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Obtain translations of documents
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
o Obtain, track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
o Publish study results for GCTO and RA where required per local legislation
Collaborate with finance/budgeting representatives for:
o Develop, control, update and close-out country and site budgets (including Split site budget)
o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators, vendors, grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures,
o Maintain tracking tools
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
07/31/2025