Job Description

Responsibilities include, but are not limited to:
• Trial and site administration:
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 and trackers

• Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents, e.g. eletronic Trial Master File (eTMF)
o Assist with eletronic Trial Master File (eTMF) reconciliation
o Execute eletronic Trial Master File (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

• Regulatory & Site Start-Up responsibilities:
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 Ethics Committee and support regulatory agencies submissions.
o Publish study results for Global Clinical Trial Operations and Regulatory Authority where required per local legislation

Meeting Planning:
o Organize meetings (create & track study memos/letters/protocols)
o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Clinical Information Systems, Clinical IT, Clinical Research Management, Clinical Study Design, Clinical Testing, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Customer-Focused, Data Analysis, Document Management, Good Clinical Data Management Practice (GCDMP), ICH GCP Guidelines, Meeting Management, Meeting Organization, New Technology Integration, Project Management, Publishing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Management, Regulatory Submissions, Translations

Preferred Skills:

Job Posting End Date:

07/20/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.