[Hiring] Clinical Trial Contracts & Budget Lead @MSD

Role 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.

• 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 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.

Qualifications

• Bachelor's Degree or higher
• 3+ years of experience in negotiating contracts or budgets
• Juris Doctor (JD) degree (preferred)

Requirements

• 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

Benefits

• 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, and compassionate and sick days