Clinical Trial Contracts & Budget Lead, Remote

Merck; Salem (OR); Remote; USD 100,000 - 150,000; Full time

Job summary

Merck is seeking a contract and budgeting professional responsible for performance and compliance of assigned protocols in line with ICH/GCP and country regulations. You will prepare, analyze, negotiate, and revise contracts and budgets throughout the contracting cycle, ensuring timely execution and adherence to SOPs and internal controls.

You will partner with CRM, CTC, CRA and COM-R to deliver Site Ready Deliverables, manage risks, and maintain documentation.

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 required site agreements and associated budgets including CTAs and related documents.
• Utilize legal fallback language and budget parameters and escalate non-compliant issues for review and approval
• Maintain databases and files for all contracts, approvals, and budgets in a uniform naming/savings convention
• Ensure timely execution of site agreements through document and metric tracking
• Perform quality control checks of agreements prior to execution
• Collaborate with CRM, CTC, CRA, COM-R and other stakeholders to deliver Site Ready deliverables and mitigate country-specific risks
• Lead and develop relationships with investigational sites and Site Management Organizations across contracting/budgeting interfaces
• Contribute to local SOP development and review/negotiation of Site Access Forms and EMR policies
• Coordinate with CTC-Fs on contingency approvals, troubleshooting, and amendments to agreements
• Contribute to or lead initiatives adding value to the business and share best practices across COM teams
• Act as SME to share knowledge and provide training related to contracting and budgeting

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, expedite, 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 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)

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

Preferred Skills:

Clinical Research

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

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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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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

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.

Requisition ID: R421622