Clinical Operations Manager Finance, Remote
$117k - $184.2kMerck Sharp & Dohme (MSD)
Job DescriptionThis 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 AssignmentsUtilize legal fallback language, budget parameters, and escalate site-specific issues that do not comply with established guidelines for review and approvalMaintain database and files for all contracts, approvals, and budgets in conformity with uniform naming and savings conventionAssume responsibility for all aspects of document and metric tracking to ensure timely execution of site agreementsPerform quality control checks of agreements prior to executionCoordinate 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 commitmentsLead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interfaceContribute 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 applicableLiaison 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/requiredContribute 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/requiredContribute to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/requiredRequired to in/directly influence investigators, external partners and country operations to successfully delivers clinical and financial contracts within fair market valueWorks 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 sitesCore competencies:Expertise of core clinical systems, tools and metricsExcellent verbal and written influencing and training/mentoring skills, in local language and EnglishStrong coordination and organizational skillsSkilled knowledge of budget and contract negotiation and understanding of how these impact study start-upAbility to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or managerAbility to make decisions independently with limited oversight from Sr.COM or managerAbility to proactively develop risk management and mitigation plans in the country and resolve issues locallyAbility to lead a team of CTCs as applicableBehavioral Competency Expectations:Problem solving is essential to this positionRequires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicableSpecific examples of common problems include:1) Issues in budget / Clinical Trial Research Agreement (CTRA) negotiations2) Quality and compliance issues3) Regulatory and legal issues4) issues related to functional area deliverables that could jeopardize protocol milestonesEffective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skillsHigh sense of accountability and urgency in order to properly prioritize deliverablesStrong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and EnglishAbility 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 peoplePositive mindset, growth mindset, capable of working independently and being self-drivenAble to directly influence site staffEducation and Experience Requirements:Bachelor's Degree or higher3+ years of experience in negotiating contracts or budgetsJuris Doctor (JD) degree (preferred)clinicaltrialjobsRequired 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 CompliancePreferred Skills: Clinical ResearchCurrent Employees apply HERECurrent Contingent Workers apply HEREUS 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:EEOC Know Your RightsEEOC GINA SupplementWe 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 ActsThe primary location for this posting is:USA - New Jersey - RahwayWhere 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 - $184,200.00This 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 .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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:RemoteShift:1st - DayValid Driving License:NoHazardous Material(s):N/AJob 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. SummaryLocation: USA - New Jersey - RahwayType: Full time
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