Investigator Contracts Lead I

Investigator Contracts Lead I

About this Role We are seeking an Investigator Contracts Lead I to join our FSP (Functional Service Provider) Clinical Operations team in Mumbai in a hybrid capacity. As an Investigator Contracts Lead I, you will lead direct site-facing contract and budget negotiations through contract execution with clinical investigator sites. This position plays a key role in site contracting, budget development, and study start-up timelines, supporting compliance with ICH-GCP and other applicable requirements. You'll collaborate with cross-functional teams, follow client and industry-standard processes, and contribute to site contracting from planning through study start-up.

Responsibilities include developing and executing initial agreements and amendments, managing the Per-Subject Cost (PSC) process, and directing site contracting activities on assigned studies, with opportunities to deepen your expertise and influence study timelines and outcomes.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through site contract negotiation, global site budget development, and escalation resolution. With diverse teams and continuous learning opportunities, the Investigator Contracts Lead I can explore career paths and expand skills across clinical research.

Key Responsibilities

• Lead study-level site contracting activities and serve as the primary point of contact for site contracting issues and timelines on assigned studies

• Directly negotiate cost, business, and contractual terms and conditions with investigators and institutions, making changes to contract templates within Legal-approved parameters

• Develop, negotiate, track, and execute global clinical study agreements with institutions and investigators, following client processes

• Manage the Per-Subject Cost (PSC) process for assigned studies, including escalation and resolution of budget and non-legal term issues from other ICLs or preferred Contract Research Organizations (pCRO)

• Work with partners to develop and oversee the global site budget process

• Balance risks to the client in budget and contractual decisions against impacts to clinical trial timelines

• Plan and identify risks to site contracting timelines through study start-up, and mitigate them in collaboration with other lines

• Direct other Investigator Contracts Leads and oversee other contracting professionals on assigned studies

• Partner with Legal, Finance, pCRO, and other divisions to manage escalations in site budgeting and contracting and to identify areas of improvement in the site contracting space

• Collaborate with invoicing specialists and Site Management Organizations (SMOs) to ensure alignment with site contracting and compensation requirements

• Candidate Profile You'll thrive in this role if you bring:

• Strengths in contract and budget negotiation, risk planning and mitigation, and leading by influence

• Experience in clinical development operations or clinical trial outsourcing

• The ability to collaborate across teams and communicate clearly

• Balanced judgment between client risk and clinical trial timelines

• Comfort working with clinical study budgets, contracting negotiation principles, and global site contracting processes

• Required Qualifications

• Bachelor's Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing, OR

• Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing

• Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities

• Working knowledge of ICH-GCP, regulatory requirements, and clinical trial processes

• Precise communication and presentation skills, with the ability to plan, identify, and mitigate risks to site contracting timelines

• Success working in a highly matrix-based organization

• Fluency in written and spoken English

• Preferred Qualifications

• Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation

• We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

• If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!