Clinical Operations Manager - Finance - Remote

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 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, identify risks and implement 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 issue 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 deliver clinical and financial contracts within fair market value. Work in partnership internally with GCTO, 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 in 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. Requires the ability to proactively identify issues and risks, analyze root cause, propose solutions and escalation to management as applicable. Effective and efficient time management, organizational and interpersonal skills, conflict management and problem‑solving skills. High sense of accountability and urgency to prioritize deliverables. Strong communication, leadership, and negotiation skills and excellent influencing and training/mentoring skills, both written and verbal, in local language and English. Ability to focus on multiple deliverables and protocols simultaneously; work effectively in a remote virtual environment with a wide range of people. Positive mindset, growth mindset, capable of working independently and 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. Juris Doctor (JD) degree (preferred). Required Skills Adaptability, Budgeting, Clinical Site Management, Clinical Trial Agreements, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Operations, Contract Agreements, Contract Negotiations, Cross‑Cultural Awareness, ICH GCP Guidelines, Leadership, Negotiation, Problem Resolution, Regulatory Compliance, Time Management. Preferred Skills None. Location Requirements US and Puerto Rico Residents Only. San Francisco Residents Only: Qualified applicants with arrest and conviction records will be considered in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: Qualified applicants, including those with criminal histories, will be considered, consistent with the City of Los Angeles Fair Chance Initiative for Hiring Ordinance. Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid model 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 model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions or those covered by a collective‑bargaining agreement unless the agreement provides for hybrid work, nor to positions that have been designated as “remote.” Salary $117,000.00 – $184,200.00. Salary range represents highest to lowest salary we believe we would pay for this role. Actual salary within the range is based on education, qualifications, experience, and other factors. Benefits We offer a comprehensive package of benefits including medical, dental, vision, healthcare, and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, compassionate and sick days. For more information, visit Employment Type Regular employee; no relocation; no visa sponsorship; 10% travel; remote; shift: 1st‑day. Equity Eligible for annual bonus and long‑term incentive, if applicable. Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment. We 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 EEOC Know Your Rights, EEOC GINA Supplement, and learn more about your rights, including under California, Colorado and other U.S. State Acts. #J-18808-Ljbffr Merck