Clinical Operations Manager

Job Description

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, 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) Research Allocation Grids (RA Grid), Master Fee Schedules (MFS), Facility Use Agreement (FUA), Reimbursement Letters, Amendments and Assignments.

• Utilize legal fallback language, budget parameters, and escalate 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 CRM, CTC, CRA, 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 SOPs.

• Review, negotiate, escalate, and facilitate business approval for Site Access Forms, EMR Access Forms, and Institution Policies as required and applicable.  

• Liaison with Payment Coordinators/CTC-Fs to issues contingency approvals, troubleshoot, and amend Agreements as required. Including oversight of CTC-F team members.

• 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, HQ functional areas and externally with vendors and sites.

Extent of Travel:

10% travel required

Qualifications, Skills & Experience

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 escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 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 and 3 years of experience in negotiating Contracts and Budgets;

​Or

• Juris Doctor (JD) degree (preferred).

Required Skills:

Adaptability, Budgeting, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Operations, Contract Agreements, Contract Negotiations, Contracts, Cross-Cultural Awareness, ICH GCP Guidelines, Leadership, Negotiation, Problem Resolution, Regulatory Compliance, Time Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

05/20/2026

*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.