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 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 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, escalate, 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 issues 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 escalate to management as applicable
Specific examples of common problems include:
Issues in budget / Clinical Trial Research Agreement (CTRA) negotiations
Quality and compliance issues
Regulatory and legal issues
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)
clinicaltrialjobs
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
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:
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.
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$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.
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
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):
N/A
Job Posting End Date:
10/19/2026
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.
