Investigator Contracts Lead I

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose. We move with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the 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!