Site Contracts Lead

Overview

The organization is seeking a Site Contracts Lead to join the Proposal & Contracts team.

This role supports biotech, medtech, and specialty pharma companies in turning life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.

This position is offered as a contract with a duration of 6-months. Candidates should be available immediately or at very short notice and should already be set up to operate as a contractor/freelancer. Preference is for candidates to have a full FTE available.

Responsibilities

• Oversee all site contracts with country experts during investigator site negotiation for assigned studies.
• Support quality of site contracts by reviewing and advising on requested language and budget changes from investigator sites.
• Serve as liaison with Sponsor on management of sites’ requests for changes; negotiate changes toward solutions with country experts.
• Establish and tailor contract templates for each new study by selecting appropriate templates and tailoring them to study requirements.
• Confirm suitability of templates with the Sponsor and establish negotiation parameters when possible.
• Confirm suitability of each template with local country experts, if necessary.
• Work with Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for regulatory submissions.
• Independently communicate with Regulatory Submission Managers on all contract-related items as needed per study.
• Escalate legal questions/issues appropriately to the line manager, Legal Counsel, or Sponsor.
• Identify site contract and budget-related risks, potential controversies, or conflicts proactively, and suggest solutions to resolve or mitigate those risks.
• Collaborate with internal study team members, including start-up team and Clinical Lead, to ensure client deliverables and expectations are met.
• Act as liaison with the client for CTAs/NDAs between country-level experts and the client for assigned studies.
• Participate in establishing study contract negotiation timelines at the beginning of each study and oversee site contract timeline milestones, deliverables, and deadlines throughout the study.
• Liaise with internal customers to review contract and budget areas that impact final execution of site contracts.
• Guide and support site contract negotiators to successful completion of study timelines and deadlines.
• Ensure clear, fair, legally binding contractual agreements are in place among the organization, clinical investigators, institutions, and clients.
• 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 gained in a CRO setting and/or clinical study-related work.
  • An advanced degree will be considered in lieu of a portion of industry experience.
• 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.
• Working knowledge of FDA Guidance Documents / EU Regulations / Local Regulations / ISO14155 regulations, drug/device development, and clinical monitoring procedures.
• Global experience is essential, ideally including prior/current experience of EU countries.

Preferred Qualifications

• Experience gained specifically in a CRO setting and/or clinical study-related contracting.
• Full FTE availability.

Compensation & Benefits

• This position is offered as a contract for a duration of 6-months.

Location

• Location not specified in the provided job description.

Equal Opportunity

The employer is an equal opportunity employer compliant with all federal guidelines. All qualified applicants receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.