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Senior Site Contracts Lead
Premier Research. Manage all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments, and associated documents for assigned studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Non-Disclosure Agreements, Clinical Trial Agreements, and Site Contracts while ensuring compliance with local legal requirements and regulations. Proven ability to lead negotiations, oversee contract timelines, and identify risks in clinical research settings.
Highest-signal resume keywords
Contract Lead ExperienceSite Contracts NegotiationKnowledge of ICH/GCP RegulationsUnderstanding of Privacy LawsFamiliarity with FDA Guidance Documents
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Contract ManagementClinical Trial AgreementsNon-Disclosure AgreementsSite Contract NegotiationRegulatory ComplianceRisk MitigationDocument Template DevelopmentClinical Monitoring ProceduresBudget ManagementPowers of Attorney
Soft Skills
LeadershipCommunicationNegotiationCollaborationProblem-Solving
Certifications & Qualifications
Undergraduate Degree in Legal StudiesUndergraduate Degree in Life Sciences
Industry Keywords
Clinical ResearchCross-Border Data TransferISO 14155 RegulationsEU RegulationsLocal Regulations
About the role
Key responsibilities & impact- Manage all aspects of implementing Non-Disclosure Agreements, Clinical Trial Agreements, Contract Amendments, and associated documents for assigned studies
- Oversee Site Contracts with country experts during investigator site negotiations
- Lead negotiation of Site Contract templates with Sponsors and liaise between Sponsors and country experts
- Assist with developing and maintaining CTA, NDA, and other document templates to ensure compliance with local legal requirements
- Support the quality of all Site Contracts
- Identify site contract and budget-related risks and suggest mitigation solutions
- Represent the Premier Research Contracts Department during Sponsor Kick-Off meetings
- Oversee site contract-related study timelines, milestones, deliverables, and deadlines
- Review and advise on Regulatory and Clinical Operations SOPs, working groups, and advertisements related to NDAs, CTAs, investigator grants, and letters of authorization of Powers of Attorney
Requirements
What you’ll need- Undergraduate degree or its international equivalent in legal studies or life sciences from an accredited institution
- 5+ years of Contract Lead experience in clinical research or a related industry
- Experience overseeing Site Contracts negotiation teams at regional/global level
- 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 data transfer
- Knowledge of ICH/GCP regulations
- Working knowledge of FDA Guidance Documents, EU Regulations, local regulations, and ISO 14155 regulations
- Knowledge of drug/device development and clinical monitoring procedures
Benefits
Comp & perks- Flexibility and balance to support your life
- Skills and opportunities for professional growth