Job Description
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, 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 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) 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 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 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 (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites.
Extent of Travel: Minimal travel required
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 negotiations, local regulatory environment and submission and approval processes, 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.
- Requires strong understanding of local regulatory environment
- 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 escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 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 and 3 years of experience in negotiating Contracts or Budgets.
- Juris Doctor (JD) degree (preferred)
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