Site Contracts Lead (Clinical Research)

Location: Remote in the United States of America

Company

hirify.global supports biotech, medtech, and specialty pharma companies in developing medicines, devices, and diagnostics.

What you will do

• Manage the implementation, negotiation, execution, and quality oversight of NDAs, CTAs, contract amendments, budgets, and other site contract documents for assigned clinical studies.
• Coordinate country experts, sponsors, investigators, institutions, regulatory submission managers, start-up teams, and clinical leads throughout contract negotiations and study timelines.
• Establish and tailor study-specific templates, confirm negotiation parameters, and review documents for local legal requirements, industry standards, and contractual clarity.
• Track contract milestones, deliverables, deadlines, risks, controversies, and potential conflicts, escalating legal issues and proposing mitigation solutions.
• Represent the Contracts Department in internal and sponsor meetings, support new contract initiatives and processes, and provide training on contractual requirements and negotiation.
• Guide, train, and mentor junior staff and provide performance feedback on project team members.

Requirements

• Experience managing site contracts and related documents for clinical studies, including NDAs, CTAs, amendments, investigator grants, and authorization documents.
• Ability to negotiate contract terms and budget changes with sponsors, investigator sites, country experts, and other stakeholders.
• Knowledge of local legal requirements, industry standards, and regulatory and clinical operations procedures related to clinical site contracts.
• Ability to manage multiple contract activities in parallel with study start-up timelines, site initiation projections, milestones, deliverables, and deadlines.
• Ability to identify contractual and budget-related risks, escalate legal questions appropriately, and develop solutions to resolve or mitigate issues.
• Ability to communicate independently with clients and internal functional teams and collaborate across study teams.

Culture & Benefits

• Remote full-time work in the United States.
• Flexible work arrangements and support for work-life balance.
• Opportunities to develop skills and advance professionally.
• Employee ideas and feedback influence ways of working.
• Equal opportunity employment compliant with federal guidelines.