Overview
This role supports site contract and contract management activities for sponsor-dedicated work and/or site start-up activities. Responsibilities include drafting, reviewing, negotiating, and managing site-specific contracts and related documents for participation in industry-sponsored clinical trials.
Responsibilities
- May lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
- Produce and review site-specific contracts from country clinical trial agreement (CTA) templates; submit proposed CTA and investigator budget for site review.
- Negotiate budgets and contracts with sites through the Site Contracts Service Centre and SSUL until resolution of issues.
- Perform quality control, arrange execution of CTAs, and archive documents into repositories while capturing required metadata.
- Review contracts for completeness and accuracy, ensuring corrections are made and documented.
- Administer contract management processes at the project level, coordinating with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents.
- Generate amended contract and/or budget documents as needed; prepare contract management documentation and streamline contract/proposal or internal processes.
- Work with Site Contracts Service Centre and Legal to harmonize site contracts to reflect sponsor master service agreement terms.
- Work with SSU lead, Clinical Operations, and Finance to validate departmental budget load and corresponding backlog.
- Identify potential contract or operational process risks and proactively work with the team to provide solutions; establish strong relationships with SSU lead, customer, and internal project teams.
- Escalate deviations to department leadership and/or Site Contracts Service Centre and/or Legal.
- Support business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings.
- Work within forecasted country/site contracting timelines; ensure compliance and track milestone progress in the agreed SSU tracking system in real time.
- Collaborate with internal and external legal, finance, and clinical operations departments; communicate and explain legal and budgetary issues.
- Maintain and support review and development of contract templates, budget templates, and site-specific files and databases.
- Serve as a key communication liaison between site contracts staff and internal/external customers; provide functional guidance and keep teams informed of contract statuses and pending issues; prepare correspondence as necessary.
- Train and mentor less experienced staff on departmental Standard Operating Procedures (SOPs), ensure quality of team work products, and maintain/update training materials.
- Participate in higher-level discussions about departmental objectives and project aims.
- Facilitate contract execution by company signatories.
- Monitor basic financial aspects of the project and the number of hours/tasks available per contract; escalate discrepancies in a timely fashion.
- Review and comply with SOPs and Work Instructions (WIs), keep training records updated, ensure timesheet compliance.
Qualifications
- Bachelor’s degree in a related field or equivalent experience
- Moderate contracts management experience, including experience in a contract research organization or pharmaceutical industry
- Practical knowledge of a professional area, typically obtained through education combined with experience
- Strong understanding of regulations, SOPs, and project requirements related to site identification
- Excellent negotiation and communication skills
- Ability to manage and review site performance metrics
- Experience managing site confidentiality agreements (CDAs) and site information forms (SIFs)
Preferred Qualifications
- 5+ years of site contracts and study start-up (SSU) experience within a global CRO or pharmaceutical sponsor environment, including ownership of multi-country studies
- Demonstrated expertise negotiating site CTAs and investigator budgets, including direct interaction with sites, sponsors, Site Contract Service Centres, and Legal teams
- Strong experience drafting and managing site-specific CTAs from country or global templates, ensuring alignment with sponsor master service agreements (MSAs) and country requirements
- Proven ability to manage contract amendments and protocol-driven changes while maintaining compliance with timelines, quality standards, and documentation requirements
- Experience serving as an escalation point for complex contract, budget, or process issues, with a track record of proactive risk identification and resolution
- Hands-on experience with SSU tracking systems and contract repositories, including real-time milestone tracking and metadata management
- Demonstrated leadership in training and mentoring junior staff, including contribution to SOPs, WIs, templates, and internal training materials
- Experience supporting business development activities, such as proposal development, bid defenses, or sponsor-facing meetings
Compensation & Benefits
- Salary range: $56,400 – $95,900 (base)
- Benefits may include:
- Company car or car allowance
- Health benefits including Medical, Dental, and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
- Note: eligibility for paid sick time may vary depending on where you work due to regulated requirements
Location
- Open to US-Remote candidates.
Certifications
- Relevant certifications in clinical research or site management preferred
Additional Information
- Tasks, duties, and responsibilities listed are not exhaustive; other responsibilities may be assigned.
- Equivalent experience, skills, and/or education will be considered.
- Nothing in this posting is intended to create an employment contract.
- Compliance with applicable laws includes providing reasonable accommodations as appropriate under the Americans with Disabilities Act.