Study Contracts Manager

Job Title: Study Contracts Manager

The Study Contracts Manager plays a key role in driving costings and contracts with U.S. clinical research sites. This position focuses on negotiating and managing site budgets and agreements for clinical trials, ensuring that all contracts with investigators, institutions, and external vendors are ethical, fair, compliant, and aligned with internal standards. The Study Contracts Manager develops and negotiates budgets based on Fair Market Value, adapts global agreement templates to local requirements, and ensures that all contract documentation supports efficient study start-up and ongoing trial execution.

Responsibilities

• Adapt global agreement templates for local use in accordance with local requirements, internal standard operating procedures, and applicable guidelines.
• Develop detailed clinical site budgets based on Fair Market Value, ensuring accuracy, consistency, and alignment with study and organizational objectives.
• Negotiate agreement language and financial terms with clinical study sites, including investigators and institutions, to reach mutually acceptable and compliant contracts.
• Serve as the primary point of contact for contract and budget negotiations with clinical research sites, maintaining clear and professional communication throughout the process.
• Interface with Legal, as needed, to ensure the integrity and compliance of each agreement and to resolve any complex contractual issues.
• Maintain up-to-date status of agreements, budgets, issues, payments, amendments, and key communications for the duration of each study.
• Ensure that final contract documents accurately reflect the agreements reached during negotiations and are consistent with internal policies and external regulations.
• Drive timely execution of all agreements to support efficient site start-up timelines and overall study delivery.
• Support internal and external audit activities by providing complete and accurate contract documentation and responding to audit queries.
• Ensure full compliance with the organization’s Code of Conduct and all relevant policies and procedures relating to people, finance, technology, and security.
• Ensure that all fully executed contracts and related documentation are properly filed and maintained within the Trial Master File (TMF).
• Consistently follow up with clinical sites to obtain required information, accelerate review and signature processes, and help achieve quicker contracting timelines.
• Collaborate with internal clinical study management teams to align contract terms and budgets with operational plans, monitoring needs, and data management requirements.

Essential Skills

• Minimum 2–4 years of experience in site contract and site budget negotiation, with at least 1 year at a contract research organization (CRO) or sponsor level.
• Minimum 2 years of hands-on experience with site contract and site budget negotiation, including direct interaction with clinical research sites.
• At least 1 year of experience using GrantsPlan or GrantManager software, or similar clinical grants and budgeting tools.
• Strong knowledge of Fair Market Value principles and their application to clinical site budget development.
• Excellent knowledge of international guidelines, including ICH-GCP.
• Basic knowledge of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

Additional Skills & Qualifications

• Bachelor’s degree in a related discipline, preferably in life sciences, law, finance, or an equivalent qualification.
• Experience working with GrantManager, GrantsPlan, or comparable clinical grant management systems, with the ability to translate this experience to internal tools.
• Ability to work cross-functionally with legal, clinical operations, finance, and other stakeholders to resolve contractual and budgetary issues.
• Proactive, self-directed approach to managing workload, priorities, and deadlines across multiple studies or sites.
• Strong interpersonal skills, with the ability to build constructive relationships with clinical research sites and internal teams.

Work Environment

This is a remote position, with a strong preference for candidates located in Eastern or Central time zones to facilitate collaboration and availability for calls with international teams, including colleagues in Poland and the United Kingdom. The role involves frequent virtual communication with internal stakeholders and external clinical research sites, and requires reliable connectivity and a professional home-office setup suitable for confidential discussions and document handling. The position offers a stable, long-term opportunity with year-over-year renewals, a salaried structure, paid time off including three weeks (15 days) of PTO and 14 holidays, and eligibility for additional benefits after the first year.

This is a Contract position based out of Wilmington, DE.

The pay range for this position is $39.90 - $45.70/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on May 15, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $40 - $46