Site Contracts Lead

Premier Research

. Oversee all site contracts with country experts during investigator-site negotiations for assigned studies .

Posted 10/19/2026contractRemote • United States, Poland, United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in overseeing site contracts and negotiations, ensuring compliance with regulatory requirements and effective communication with stakeholders. Proficient in managing contract-related risks and delivering client-focused solutions in a clinical research environment.

Highest-signal resume keywords

Contract NegotiationBudget DevelopmentRegulatory ComplianceGlobal ExperienceLegal Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Contract LanguageBudget DevelopmentNegotiation SkillsRegulatory SubmissionClinical Monitoring ProceduresPrivacy Laws KnowledgeFDA Guidance DocumentsEU RegulationsISO 14155 RegulationsNon-Disclosure Agreements

Soft Skills

CommunicationCollaborationProblem-SolvingRisk ManagementConflict Resolution

Certifications & Qualifications

Undergraduate Degree in Legal StudiesLaw Degree Preferred

Industry Keywords

CRO SettingClinical StudyInvestigator GrantsPowers of AttorneyLetters of AuthorizationCross-Border Data TransferStudy Contract TemplatesClient DeliverablesStudy TimelinesMilestones

About the role

Key responsibilities & impact

Oversee all site contracts with country experts during investigator-site negotiations for assigned studies
Review and advise on request language and budget changes requested by investigator sites
Liaise with sponsors regarding site change requests and negotiate solutions with country experts
Establish and tailor study contract templates and confirm suitability with sponsors and local country experts
Provide final CTAs and/or budgets per country/site for regulatory submissions
Communicate with regulatory submission managers on contract-related study items
Escalate legal questions and issues to the line manager, Premier’s Legal Counsel, or sponsor
Identify site contract and budget risks, controversies, and conflicts and suggest mitigation solutions
Collaborate with study team members, including the start-up team and Clinical Lead, to achieve client deliverables
Liaise with clients regarding CTAs/NDAs between country experts and clients
Establish and oversee study contract negotiation timelines, milestones, deliverables, and deadlines
Review contract or budget areas affecting final execution of site contracts
Guide site contract negotiators toward successful completion of study timelines and deadlines
Ensure clear, fair, and legally binding contractual agreements among Premier Research, 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

What you’ll need

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
Experience preferably gained in a CRO setting / clinical study-related environment
An advanced degree may 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, ISO 14155 regulations, drug/device development, and clinical monitoring procedures
Global experience is essential, ideally including prior/current experience of EU countries
Available immediately or at very short notice
Already set up to operate as a contractor/freelancer
Full FTE availability preferred

Benefits

Comp & perks

Flexibility and balance to accommodate life requirements
Contract opportunity with a duration of 6 months
Full FTE availability preferred