Clinical Operations Manager Finance, Remote

Merck; Juneau (AK); Remote; USD 117,000 - 184,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision coverage

Paid holidays

Vacation and sick leave

Job summary

Merck in Rahway, NJ is seeking a seasoned Contract Specialist to ensure performance and regulatory compliance for assigned clinical trial protocols. You will prepare, analyze, and negotiate clinical research contracts and budgets across all cycle stages, coordinating with clinical and regulatory teams to meet country timelines.

You will manage site agreements, budgets, and related documents, applying SOPs and best practices, while liaising with vendors and sites to optimize outcomes and value.

Qualifications

• Bachelor's Degree or higher.
• 3+ years of experience in negotiating contracts or budgets.
• Juris Doctor (JD) degree (preferred)

Responsibilities

• Prepare, analyze, negotiate, and execute site agreements and budgets including CTAs, MTAs, CDAs, MCAs, IRAG, MFS, FUA, reimbursement letters, amendments and assignments.
• Utilize legal fallback language and budget parameters; elevate non-compliant site issues for review.
• Maintain database/files for contracts, approvals, budgets with uniform naming and saving conventions.
• Own all aspects of document and metric tracking to ensure timely execution of site agreements.
• Perform quality control checks of agreements prior to execution.
• Coordinate with CRM, CTC, CRA, COM-R, and others to deliver Site Ready Deliverables; identify risks and implement mitigations.
• Lead and develop relationships with investigational sites and SMOs across contracting and budgeting interface.
• Contribute to development of local SOPs.
• Review, negotiate, escalate, and obtain approvals for Site Access Forms, EMR Access Forms, and Institution Policies.
• Liaise with CTC-Fs to issue contingency approvals, troubleshoot, and amend agreements as needed.
• Contribute or lead initiatives adding value to the business; support COM/team knowledge transfer.

Skills

Clinical Site Management

Clinical Trial Compliance

Clinical Trial Management

Clinical Trials Operations

ICH GCP Guidelines

Influencing Skills

Leadership

Negotiation

Problem Solving

Project Management

Quality Control Management

Regulatory Compliance

Education

Bachelor's Degree or higher

Juris Doctor (JD) degree (preferred)

Job description

Job Description

This role is accountable for performance and compliance for assigned protocols in a country in compliance with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. Clinical Operations Manager (COM), Head COMs or Therapy Area Heads (TAH), the person is responsible for preparing, analyzing, negotiating, and revising Clinical Research related contracts and budgets through all phases of the contract cycle.

Responsibilities include, but are not limited to:

• Prepare, analyze, negotiate, and execute required site agreements and associated budgets including Clinical Trial Research Agreements (CTRA), Master Clinical Trial Research Agreements (MCTRA), Confidentiality Disclosure Agreements (CDA), Multiple Confidentiality Disclosure Agreements (MCDA), Imaging Research Allocation Grid (IRAG), Master Fee Schedules (MFS), Facility Use Agreement (FUA), Reimbursement Letters, Amendments and Assignments

• Utilize legal fallback language, budget parameters, and elevate site-specific issues that do not comply with established guidelines for review and approval

• Maintain database and files for all contracts, approvals, and budgets in conformity with uniform naming and savings convention

• Assume responsibility for all aspects of document and metric tracking to ensure timely execution of site agreements

• Perform quality control checks of agreements prior to execution

• Coordinate and liaise with Clinical Research Manager (CRM), Clinical Trial Coordinator (CTC), Clinical Research Associate (CRA), Clinical Operations Manager - Regulatory (COM-R) (Finance and legal if, appropriate) to collaborate on Site Ready Deliverables including identifying risks and implementing mitigation plans to meet country deliverable timelines and commitments

• Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface

• Contribute to the development of local Standard Operating Procedures (SOPs)

• Review, negotiate, escalation, and facilitate business approval for Site Access Forms, Electronic Medical Record (EMR) Access Forms, and Institution Policies as required and applicable

• Liaison with Payment Coordinators / Clinical Trial Coordinator - Finance (CTC-Fs) to issue contingency approvals, troubleshoot, and amend Agreements as required.

• Contribute or lead initiatives and projects adding value to the business, as appropriate/required

• Contribute strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required

• Contribute to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

• Required to in/directly influence investigators, external partners and country operations to successfully delivers clinical and financial contracts within fair market value

• Works in partnership internally with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarters (HQ) functional areas and externally with vendors and sites

Core competencies:

• Expertise of core clinical systems, tools and metrics

• Excellent verbal and written influencing and training/mentoring skills, in local language and English

• Strong coordination and organizational skills

• Skilled knowledge of budget and contract negotiation and understanding of how these impact study start-up

• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager

• Ability to make decisions independently with limited oversight from Sr.COM or manager

• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally

• Ability to lead a team of CTCs as applicable

Behavioral Competency Expectations:

• Problem solving is essential to this position

• Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and elevate to management as applicable

• Specific examples of common problems include:

• 1) Issues in budget / Clinical Trial Research Agreement (CTRA) negotiations

• 2) Quality and compliance issues

• 3) Regulatory and legal issues

• 4) issues related to functional area deliverables that could jeopardize protocol milestones

• Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills

• High sense of accountability and urgency in order to properly prioritize deliverables

• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English

• Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people

• Positive mindset, growth mindset, capable of working independently and being self-driven

• Able to directly influence site staff

Education and Experience Requirements

• Bachelor's Degree or higher

• 3+ years of experience in negotiating contracts or budgets

• Juris Doctor (JD) degree (preferred)

Required Skills:

Clinical Site Management, Clinical Trial Compliance, Clinical Trial Management, Clinical Trials Operations, ICH GCP Guidelines, Influencing Skills, Leadership, Negotiation, Problem Solving, Project Management, Quality Control Management, Regulatory Compliance

Preferred Skills:

Clinical Research

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):

N/A

Job Posting End Date:

10/19/2026

Requisition ID:

R421622

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Primary Location:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

Salary Range for Primary Location:

$117,000.00 - $184,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .