Site Contracts Specialist

Overview

This role supports site contract development and contract management for industry-sponsored clinical trials. Responsibilities include producing and negotiating site-specific contracts, coordinating execution, managing document archival, and ensuring compliance with relevant procedures.

Responsibilities

• May lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Produce site-specific contracts from country clinical trial agreement (CTA) template; review and own site-specific contracts generated from the country template.
• Submit proposed CTA and investigator budget for site review.
• Negotiate budget and contract with sites and via Site Contracts Service Centre and SSUL with the sponsor until resolution of issues.
• Perform quality control, arrange execution of CTAs, and archive documents into repositories while capturing metadata.
• Review contracts for completeness and accuracy, ensuring corrections are documented and made appropriately.
• 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 and streamline contract/proposal or internal processes.
• Work with Site Contract Service Center and Legal to harmonize site contracts to reflect sponsor master service agreement terms.
• Work with SSU lead, Clinical Operations, and Finance to validate the load of departmental budgets and corresponding backlog.
• Identify operational risk related to contracts or processes and proactively work within the team to provide solutions.
• Establish strong working relationships with SSU lead, customer, and internal project teams; escalate deviations to department leadership and/or Site Contract Service Center 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 timelines are met and track milestone progress in the agreed-upon SSU tracking system in real time.
• Collaborate with internal and external legal, finance, and clinical operations; communicate and explain legal and budgetary issues.
• Maintain and support the 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 or pending issues.
• Prepare correspondence as necessary.
• Train and mentor less experienced staff on departmental Standard Operating Procedures (SOPs); maintain and update training materials for the site contract team.
• Participate in higher-level discussions regarding company goals, departmental objectives, and specific project aims.
• Facilitate execution of contracts 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 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 with ability to manage challenging priorities; 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.
• 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

• Management experience.

Compensation & Benefits

• Not specified in the provided job description.

Location

• Not specified in the provided job description.

Additional Information

• Tasks, duties, and responsibilities listed are not exhaustive; other tasks may be assigned at the organization’s discretion.
• Equivalent experience, skills, and/or education may be considered.
• Nothing in this posting should be construed to create an employment contract.
• The organization may determine what constitutes equivalency to the qualifications described.
• Reasonable accommodations are provided when appropriate to assist employees or applicants in performing essential functions.
• Any language in the posting is intended to comply with applicable legislation in each country where the organization operates, including obligations related to recruitment and employment.