Site Contracts Specialist / Sr or Lead - Sponsor - dedicated

Overview

This dedicated sponsor role supports clinical trial site contracting and start-up activities. The position administers contract management processes, negotiates and prepares site contracts and budgets, coordinates stakeholders, tracks milestones, and helps ensure compliance with applicable regulations, standard operating procedures (SOPs), work instructions (WIs), and project requirements.

Roles in the Site Start-Up/Site Identification job family manage and execute site identification activities, including completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs), maintaining and reporting site performance metrics, serving as a primary contact for investigative sites, and tracking site-identification completion.

Responsibilities

• Administer project-level contract management processes, coordinating protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents.
• With supervision, lead multi-country projects involving the negotiation and preparation of contracts, budgets, and related documents for industry-sponsored clinical trials.
• Support agreement on country template contracts and budgets, produce site-specific contracts, and assist with submissions for proposed site contracts and budgets.
• Support budget and contract negotiations with sites, the Site Contracts Service Centre, Site Start-Up staff, and the sponsor until issues are resolved.
• Perform quality control, arrange execution of clinical trial agreements (CTAs), archive documents in repositories, and capture required metadata.
• Review contracts for completeness and accuracy and ensure corrections are properly made and documented.
• Support business development activities and represent site contracts and Site Start-Up at internal and customer meetings.
• Work with Contract Managers and team members to actively manage ongoing contract issues and follow up on outstanding items.
• Generate amended contract and budget documents as needed and prepare contract management documentation for projects.
• Streamline contract, proposal, and internal processes and introduce practical ideas and solutions.
• Work within forecasted country and site contracting timelines, track milestone progress in the agreed Site Start-Up tracking system in real time, and escalate delays or discrepancies as appropriate.
• Collaborate with internal and external legal, finance, and clinical operations teams, including communicating and explaining legal and budgetary issues.
• Facilitate contract execution by authorized signatories.
• Maintain contract templates, site-specific files, and databases.
• Train and mentor less experienced staff on departmental SOPs and ensure the quality of team work products.
• Maintain and update training materials for the site contracts team.
• Act as a communication liaison between site contracts staff and internal and external customers.
• Provide functional guidance and keep internal and external teams informed of contract statuses and pending issues.
• Prepare correspondence as necessary.
• Monitor basic project financial aspects and the number of hours or tasks available per contract, escalating discrepancies in a timely manner.
• Review and comply with SOPs and WIs, keep training records current, and ensure timesheet compliance.
• Provide quality feedback and guidance to peers and contribute to Site Start-Up training and quality assurance plans, including updates to SOPs and WIs.

Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, a related field, or an equivalent combination of education and experience. An advanced degree is preferred.
• High-level contracts management experience.
• Experience in a contract research organization or pharmaceutical industry is essential.
• Strong knowledge of the clinical development process and legal and contracting parameters.
• Strong computer skills, including Microsoft Office Suite.
• Excellent understanding of the 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 negotiating and problem-solving skills.
• Excellent written and oral communication, presentation, documentation, and interpersonal skills, with a strong team orientation.
• Strong organizational skills and a proven ability to manage multiple projects.
• Customer-focused approach and the ability to manage challenging priorities while remaining flexible and adaptable in stressful situations.
• Quality-driven approach to all managed activities.
• Ability to mentor, lead, and motivate more junior staff.

Scope and Working Conditions

• Established and productive individual contributor with responsibility in a professional or technical discipline or specialty.
• May manage two or fewer employees, direct the work of lower-level professionals, or manage defined components of projects or processes.
• The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies using knowledge and skills typically acquired through advanced education.
• Equivalent experience, skills, and education may be considered.
• Duties and responsibilities listed are not exhaustive; additional tasks may be assigned as needed.
• The role is subject to applicable employment, equal opportunity, disability accommodation, and other legal requirements in the country of employment.