Overview
Sr Site Contracts Specialist (assigned to client) — Remote in USA
This role supports end-to-end site contract management for participation in industry-sponsored clinical trials, including drafting, negotiation, review, quality control, execution coordination, and contract-related administration.
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 CTA template; submit proposed CTA and investigator budget for site review.
- Negotiate budget and contract with site and through Site Contracts Service Centre and SSUL with Sponsor until issues are resolved.
- Perform quality control; arrange execution of CTAs; archive documents into repositories and capture metadata.
- Review contracts for completeness and accuracy; ensure corrections are appropriately made and documented.
- Administer contract management processes, coordinating with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
- Generate amended contract and/or budget documents as necessary; prepare contract management documentation; streamline contract/proposal and internal processes; initiate and introduce creative ideas and solutions.
- Work closely with Site Contract Service Centre and Legal to harmonize site contracts to reflect sponsor master service agreement terms.
- Work closely with SSU lead, Clinical Operations, and Finance to validate departmental budget load and corresponding backlog.
- Identify contract/process operational risks and proactively provide solutions; establish strong working relationships with SSU lead, customer, and internal project teams.
- Escalate deviations to department leadership and/or Site Contract Service Centre and/or Legal Department.
- Provide support to business development and represent site contracts/Site Start-Up (SSU) in internal or customer meetings.
- Work within forecasted country/site contracting timelines; ensure compliance; track milestone progress in agreed SSU tracking system in real time.
- Collaborate with internal and external legal, finance, and clinical operations teams; 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 stakeholders informed of contract status and pending issues; prepare correspondence as necessary.
- Train and mentor less experienced staff on departmental Standard Operating Procedures (SOPs); ensure quality of team deliverables; maintain and update training materials for site contract team.
- Participate in higher-level discussions about overall organizational goals, departmental objectives, and project aims.
- Facilitate contract execution by company signatories.
- Monitor basic financial aspects of the project, including the number of hours/tasks available per contract; escalate discrepancies in a timely manner.
- Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner; keep training records updated accordingly and ensure timesheet compliance.
Requirements
- BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
- Advanced degree preferred.
- Moderate contracts management experience, including experience in a contract research organization or pharmaceutical industry.
- Strong knowledge of the clinical development process and legal and contracting parameters.
- Strong computer skills in Microsoft Office Suite.
- Customer focused; ability to manage challenging priorities and remain flexible and adaptable in stressful situations.
- Excellent understanding of clinical trial process across Phases II–IV and ICH GCP.
- Good understanding of clinical protocols and associated study specifications.
- Excellent understanding of clinical trial start-up processes.
- Project management experience in a fast-paced environment.
- Good vendor management skills.
- Strong organizational skills with proven ability to handle multiple projects.
- Excellent communication, presentation, and interpersonal skills.
- Quality-driven in all managed activities.
- Strong negotiating skills.
- Strong problem-solving skills.
- Ability to mentor and motivate more junior staff.
- Demonstrate ability to provide quality feedback and guidance to peers.
- Contribute to a training and Quality assurance plan within SSU and update SOPs/WI.
Preferred Qualifications
Compensation & Benefits
- Salary Range: $56,400.00 - $95,900.00 (base salary). Actual salary will vary based on factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
- Benefits may include:
- Company car or car allowance
- Health benefits: Medical, Dental, 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
Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work.
Location
Additional Information
- Tasks, duties, and responsibilities listed in the job description are not exhaustive; other tasks may be assigned.
- Equivalent experience, skills, and/or education will be considered.
- Nothing in this posting is intended to create an employment contract.
- The organization is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate.