Site Contracts Lead

Overview

The organization is seeking a Site Contracts Lead to join the Regulatory Submissions and Contracts team.

This role supports biotech, medtech, and specialty pharma organizations by helping translate scientific innovation into new medicines, devices, and diagnostics. Responsibilities focus on oversight of site contracts, negotiation support, risk identification, and coordination with internal and external stakeholders.

Responsibilities

• Provide oversight of all site contracts with country experts during investigator site negotiation for assigned studies.
• Support the quality of site contracts by reviewing and advising on request language and budget changes submitted by investigator sites.
• Serve as a liaison with the sponsor to manage site request changes; negotiate changes toward solutions with country experts.
• Establish and tailor contract templates for each new study by selecting appropriate templates and confirming suitability with the sponsor and, when necessary, local country experts.
• Work with Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions.
• Independently communicate with Regulatory Submission Managers on contract-related items as needed per study.
• Escalate legal questions/issues appropriately to the Line Manager, the organization’s Legal Counsel, or the sponsor.
• Proactively identify site contract and budget-related risks, potential controversies, and conflicts; suggest solutions to resolve or mitigate them.
• Participate in internal and external project-related meetings as needed.
• Interact with clients and other functional areas as a secondary project contact for contracting issues and questions.
• Collaborate with study team members, including the start-up team and Clinical Lead, to ensure client deliverables and expectations are met.
• Act as a liaison between country-level experts and the client regarding CTAs/NDAs for assigned studies.
• Help establish study contract negotiation timelines at the beginning of the study and oversee site contract timeline milestones, deliverables, and deadlines throughout the study lifecycle.
• Liaise with internal customers to review contract or budget areas that impact final execution of site contracts.
• Guide and support site contract negotiators to successful completion of study timelines and deadlines.
• Ensure contractual agreements among the organization, clinical investigators, institutions, and clients are clear, fair, and legally binding.
• Review and advise on Regulatory and Clinical Operations SOPs, WGs, and ADs related to NDAs, CTAs, investigator grants, and Letters of Authorization or Powers of Attorney.

Requirements

• Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution; law degree preferred.
• At least 2 years of legal experience with global contract language, budget development, and negotiations; preferably clinical study related.
• An advanced degree will be considered in lieu of a portion of industry experience.
• At least 1 year of CRO experience.
• Ability to work with internal and external customers/vendors to meet project-specific goals.
• Knowledge of basic requirements of contracts, non-disclosure agreements, powers of attorney, and related documents.
• Knowledge of Privacy Laws and regulations pertaining to cross-border transfer of data.
• Knowledge of ICH/GCP regulations.
• Working knowledge of FDA Guidance Documents / EU Regulations / Local Regulations / ISO14155 regulations, drug/device development, and clinical monitoring procedures.
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job.
• Knowledge of national/local health systems and cultural/professional practices appropriate to the country/region where site start-up activities will be carried out.
• Strong verbal and written communication and negotiation skills.
• Excellent organizational and time-management skills, including prioritization to meet deadlines.
• Ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Customer service-focused approach both internally and externally.
• Accountable, dependable, and demonstrates strong commitment to the role.

Preferred Qualifications

• Law degree.

Compensation & Benefits

Not specified in the provided job description.

Location

Not specified in the provided job description.