Overview
This role supports clinical research study startup by leading preparation, negotiation, and execution of clinical site agreements. You will partner with clinical sites, sponsors, legal teams, and cross-functional stakeholders to drive contract negotiations from initial draft through final execution.
Responsibilities
- Prepare and customize country-specific contract templates and site agreement documentation to support clinical trial startup activities.
- Lead negotiations of site contract language, budgets, amendments, and related agreements through execution.
- Review contract terms, study budgets, and associated costs to ensure accuracy, compliance, and alignment with approved parameters.
- Partner with sponsors, clinical sites, legal, data privacy, regulatory, and study teams to resolve issues and advance negotiations.
- Identify and escalate contractual risks, budget concerns, and site-related challenges to appropriate stakeholders.
- Conduct quality reviews of contracts and supporting documents before signature and final execution.
- Facilitate contract execution and distribution of fully executed agreements to relevant stakeholders and systems.
- Maintain accurate contract tracking tools and provide timely updates on negotiation status, timelines, and deliverables.
- Prioritize competing deadlines and respond effectively to urgent requests while supporting study startup objectives.
Requirements
- Bachelor’s degree or equivalent in Business Administration, Finance, Science, or a related field.
- 1 to 3 years of experience within clinical research, pharmaceutical, CRO, investigator/site contracts, or related legal field.
- Proficiency in English with excellent verbal and written communication skills.
- Knowledge of ICH-GCP guidelines, clinical trial regulations, and applicable local regulatory requirements.
- Experience negotiating contract terms, budgets, amendments, and related agreements with clinical research sites.
- Strong analytical and problem-solving skills, including the ability to identify risks, resolve issues, and interpret contractual and financial information.
- Proficiency with Microsoft Word, Excel, and Outlook, along with experience using contract management systems and tools.
- Ability to manage multiple priorities, collaborate effectively across functions, and maintain a high level of accuracy and attention to detail.
Preferred Qualifications
Compensation & Benefits
- United States of America: $60,000.00 - $119,000.00 annually (for hourly paid positions, the stated salary range reflects hourly rates).
- Benefits package provided and varies by location.
Location
Remote role open to candidates based in US Remote. Collaboration with global teams across multiple time zones is required.