Principal Site Contracts Lead

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee the negotiation of clinical study agreements (CTAs) at the study level.

• Lead the finalization and execution of CTA documents, including contractual language, terms, financial attachments, and investigator grant budgets.

• Ensure that global CTA negotiations align with sponsor and Company guidelines.

• Identify issues related to investigator budgets at the project and Company levels and implement effective solutions.

• Build and maintain productive relationships with clients and internal project teams.

• Contribute to global operational initiatives at the project, Sponsor, or relationship levels.

• Act as a strategic liaison for site contracting and budgeting objectives.

• Develop, maintain, and update training materials.

• Serve as a subject matter expert and escalation point for global site contracting challenges.

• Supervise contract and budget negotiations, including the escalation of out-of-parameter requests.

• Provide guidance to study teams and Sponsors on industry trends, best practices, risks, and mitigation strategies.

• Plan the strategy for contract execution and forecast site-specific timelines for execution.

• Coordinate communications and status updates among study stakeholders and global negotiators.

• Prepare site contractual templates, payment terms, negotiation parameters, and processes.

• Identify operational risks and proactively formulate solutions.

• Create and maintain document status reports and update departmental systems.

• Collaborate with legal, finance, and clinical operations departments.

• Manage discussions related to fair market value concerning investigator budgets and payment terms.

• Identify best practices, investigate root causes, and propose effective solutions.

• Train and mentor less experienced team members.

• Represent the Company at professional meetings or seminars.

• Provide support for help desk and issue-resolution pathways.

• Lead internal training sessions and process improvement initiatives as required.

• Participate in business development presentations as a subject matter expert in site contracts and investigator budgets.

• Perform other assigned duties.

⛳️ Requirements

• Bachelor’s degree in life sciences, a health-related field, or a comparable combination of education and experience.

• Extensive experience in the CRO/pharmaceutical industry with relevant clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience.

• Comprehensive knowledge of applicable regulations, drug development, and clinical project management procedures.

• Strong presentation, documentation, and interpersonal skills.

• Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, Outlook, and Internet applications.

• Capable of managing multiple tasks to meet deadlines while delivering high-quality work in a fast-paced environment.

• Exceptional attention to detail and effective oral and written communication skills.

• Ability to work independently to meet deadlines.

• Outstanding leadership skills with the capability to teach and mentor team members.

• Proficient in coaching employees to achieve performance objectives.

• Strong background in resolving issues, meeting customer deliverables, and promoting best practices at the organizational or customer portfolio level.

• Minimal travel may be required, up to 25%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a total rewards program.

• Company car or car allowance.

• Comprehensive Medical, Dental, and Vision health benefits.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions and bonuses based on company and individual performance.

• Flexible paid time off (PTO) and sick leave.