Clinical Trial Contracts & Budget Lead, Remote

MSD Malaysia; Rahway (NJ); Remote; USD 117.000 - 184.000; Vollzeit

Zusammenfassung

MSD Malaysia seeks an experienced contracts and budgets professional to ensure performance and compliance for clinical trial agreements across the country. You will prepare and negotiate site agreements, budgets, and related documents while maintaining robust records and collaborating with cross‑functional teams.

The role requires strong negotiation, project management, and regulatory knowledge under ICH‑GCP, with the ability to lead a contracting interface and mentor junior staff.

Qualifikationen

• Bachelor's degree or higher with 3+ years negotiating contracts or budgets
• Juris Doctor (JD) degree preferred for legal background
• Experience in regulatory compliance and ICH‑GCP guidelines

Aufgaben

• Prepare, analyze, negotiate, and execute site agreements and budgets (CTRA/MCTRA, CDA, MCDA, IRAG, MFS, FUA).
• Maintain databases and files for contracts, approvals, and budgets.
• Coordinate with CRM, CRA, and COM‑R to review site deliverables and mitigate risks.
• Develop SOPs and educate COM team; act as SME on processes and best practices.
• Build and sustain relationships with investigational sites and Site Management Organizations.

Kenntnisse

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

Clinical Research

Ausbildung

Bachelor's degree or higher

Juris Doctor (JD) degree

Jobbeschreibung

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

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, elevate, 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 issue 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 deliver 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

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

Company Commitment to Inclusion

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.

Equal Opportunity

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 EEOC GINA Supplement. 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.

Salary and Benefits

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.

Employment Terms

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

Residency Requirements

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.

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.