POSITION SUMMARY
The Site Contract Manager provides functional leadership and oversight of investigator site contracting and budgeting activities for multi-center clinical studies. This role serves as the primary subject matter expert for site contracts, site budgets, and associated financial and contractual risk management. The position partners closely with Sponsors, Legal, Finance, Study Start-Up, Project Management, and investigative sites to ensure timely contract execution, proactive risk mitigation, and achievement of study start-up timelines.
The Site Contract Manager is responsible for leading complex contract negotiations, mentoring and developing team members, driving process improvements, supporting departmental resource planning, and contributing to strategic initiatives that enhance operational efficiency and study activation performance.
DUTIES AND RESPONSIBILITIES
Contracting and Budget Leadership
- ✓Lead investigator site contracting activities from study award through execution of all site agreements and subsequent amendments.
- ✓Serve as the primary contracting and site budget lead for assigned studies and strategic Sponsor relationships.
- ✓Directly negotiate and/or oversee negotiations of Clinical Trial Agreements (CTAs), Confidentiality Agreements (CDAs), Letters of Indemnification (LOIs), study budgets, and related amendments.
- ✓Establish contract and budget negotiation strategies that align with Sponsor expectations while protecting ProSciento's financial and operational interests.
- ✓Ensure site contracts and budgets comply with company policies, legal requirements, Sponsor agreements, Fair Market Value (FMV) standards, and study-specific parameters.
- ✓Function as the escalation point for complex contractual, legal, operational, and budgetary negotiation issues.
Study Start-Up & Operational Execution
- ✓Partner with Study Start-Up and Project Management teams to support timely site activation and achievement of study milestones.
- ✓Develop and maintain study-specific contract execution plans, timelines, and tracking tools.
- ✓Monitor contract cycle times and proactively identify risks that could delay site activation, enrollment, or overall study timelines.
- ✓Provide regular reporting and status updates to internal stakeholders and Sponsors regarding contracting progress and potential risks.
- ✓Ensure accurate documentation, filing, tracking, and audit readiness of all contract-related records.
Financial & Budget Management
- ✓Lead site budget strategy development and negotiation activities.
- ✓Evaluate site budget requests for reasonableness, consistency, protocol requirements, and fair market value compliance.
- ✓Identify opportunities for cost containment while maintaining strong site relationships.
- ✓Support financial forecasting activities related to site contracting timelines and budget commitments.
- ✓Review and resolve budget variances, escalations, and financial exceptions requiring senior-level review.
Risk Management & Compliance
- ✓Proactively identify contractual, operational, regulatory, and financial risks associated with site agreements.
- ✓Develop and implement mitigation strategies to minimize study delays and financial exposure.
- ✓Ensure compliance with internal policies, SOPs, Sponsor requirements, applicable regulations, and industry best practices.
- ✓Conduct quality reviews of contracts and budgets to ensure completeness, accuracy, and consistency.
Leadership & Team Development
- ✓Mentor, train, and develop Site Contract Associates and Site Contract Managers.
- ✓Provide functional guidance and support for negotiation strategies, issue resolution, and process execution.
- ✓Participate in workforce planning discussions and provide recommendations regarding staffing and resource allocation.
- ✓Support onboarding and development of new team members.
- ✓Promote knowledge sharing and continuous improvement across the Budgets & Contracts team.
Process Improvement & Innovation
- ✓Lead initiatives to improve contracting efficiency, cycle times, quality, and scalability.
- ✓Develop, review, and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), templates, process maps, and best practices.
- ✓Identify opportunities to leverage technology and automation to improve site contracting and budgeting processes.
- ✓Partner with leadership to implement strategic process improvements and organizational initiatives.
JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education
- ✓Bachelor's Degree in Finance, Economics, Business Administration, Healthcare Administration, Life Sciences, or a related field, preferred.
Required
- ✓Minimum 7 years of clinical research site contract and budget negotiation experience.
- ✓Minimum 3 years managing complex site contract negotiations across multi-center clinical trials.
- ✓Experience working within a CRO, Sponsor, or clinical research environment.
- ✓Demonstrated experience negotiating CTAs, CDAs, site budgets, amendments, and related agreements.
- ✓Experience mentoring team members and serving as a subject matter expert.
Preferred
- ✓Experience supporting global and multi-country clinical studies.
- ✓Experience working directly with Sponsor legal and procurement teams.
- ✓Experience with contract lifecycle management systems and clinical trial management platforms
KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED
Competencies
- ✓Customer Focus: Demonstrates a strong commitment to meeting the needs and expectations of internal and external customers. Builds trusted relationships, gathers relevant customer insights, and applies them to improve service and outcomes.
- ✓Functional/Technical Skills: Possesses the functional and technical knowledge and skills required to perform responsibilities effectively and deliver high-quality results.
- ✓Communication: Communicates clearly, professionally, and effectively with clients, management, and cross-functional stakeholders. Demonstrates excellent written, verbal, and interpersonal communication skills and provides timely, accurate information to support effective decision-making.
- ✓Collaboration: Works effectively and independently while partnering across functions to achieve organizational objectives. Builds productive working relationships and demonstrates sound judgment in resolving issues.
- ✓Negotiating: Navigates challenging situations with diplomacy and professionalism. Effectively negotiates with internal and external stakeholders, resolves differences, and identifies solutions while maintaining positive relationships.
- ✓Priority Setting: Effectively organizes information, manages projects, establishes priorities, and focuses resources on activities that have the greatest impact. Identifies and addresses obstacles to achieving goals.
- ✓Time Management: Manages multiple responsibilities effectively and efficiently, meets deadlines, and appropriately balances competing priorities.
- ✓Problem Solving: Demonstrates flexibility and sound judgment in ambiguous, changing, and complex environments. Independently identifies and resolves problems while responding to changing demands in a professional and timely manner.
The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.
ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.
ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
