Job Description

Under the oversight of the line-manager, mentor, and/or rotational assignment manager, this position involves a 24-36 month committed experience rotating throughout Research and Development Division/Global Clinical Trial Operations in various clinical trial functions in preparation for movement into next roles.

This role will collaborate throughout Global Clinical Trial Operations local, country, and HQ levels, with trial management, data management, country operations and other areas. This role will rotate through various organizations, teams, and functions within Research and Development Division and Global Clinical Trial Operations to gain broad clinical research exposure and experience in support of clinical trial execution.

The role assists in meeting Site Ready objectives, IRB/ERC and Health Authorities submissions, study execution objectives, data management responsibilities, clinical /non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable, in support of clinical trial delivery.

Responsibilities may include, but are not limited to:

Trial and site administration and management:

• Track essential documents and report issues as applicable

• 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, in collaboration with other country roles (if applicable)

Document and data 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

• 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 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.

Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives to:

• Maintain contracts (e.g. CTRAs)

• Track and report contract negotiations

• Update and maintain contract templates (in cooperation with Legal Department)

• Monitor and track adherence and disclosures

• Maintain tracking tools

• Obtain and process FCPA documentation in a timely manner

Meeting Attendance & Planning:

• Organize meetings (create & track study memos/letters/protocols

• Support local investigator meetings where applicable

Skills:

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills

• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines

• Proficient 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

• 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

Experience Requirements:

• Clinical Research, relevant healthcare or transferrable experience/skills preferred.

Educational Requirements:

• High School Diploma or equivalent with completed job training (office management, administration, finance, life sciences, engineering, project management, healthcare, education preferred) required.

• Bachelor’s Degree preferred.

#MSJR

Required Skills:

Adaptability, Adaptability, Clinical IT, Clinical Research Management, Clinical Study Design, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Management, Clinical Trials, Contract Lifecycle Management (CLM), Contract Management, Customer-Focused, Data Analysis, Data Management, Document Management, Good Clinical Data Management Practice (GCDMP), ICH GCP Guidelines, Medical Research, Medical Supply Management, New Technology Integration, Office Administration, Project Management, Regulatory Compliance, Regulatory Submissions, Supply Change Management {+ 1 more}

Preferred Skills:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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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:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

11/14/2025

*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.