Site Contract Specialist II

Overview

This role administers site contract management processes for clinical trial projects, coordinating key documents and ensuring contract execution, quality control, and compliant timelines.

Responsibilities

• Administer all contract management processes, coordinating relevant documentation at the project level, including protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents.
• Lead (with supervision) multi-country projects by negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Support agreement on country template contract and budget, produce site-specific contracts from the template, and support submissions for proposed contract and budget for sites.
• Support negotiation of budgets and contracts with sites via the Site Contracts Service Centre and SSUL with the Sponsor until resolution of issues.
• Perform quality control on contracts, arrange execution of CTAs, and archive documents into repositories while capturing required metadata.
• Review contracts for completeness and accuracy; ensure corrections are made and appropriately documented.
• Support business development activities and represent site contracts / Site Start-Up (SSU) at internal or customer meetings.
• Work with Contract Managers and team members to actively manage ongoing contract issues, including follow-up on outstanding items.
• Generate amended contract and/or budget documents as necessary; prepare contract management documentation; streamline contract/proposal or internal processes; and contribute creative ideas and solutions.
• 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 groups; communicate and explain legal and budgetary issues.
• Facilitate contract execution by company signatories.
• Maintain contract templates and site-specific files and databases.
• Train and mentor less experienced staff on departmental Standard Operating Procedures (SOPs), ensuring quality of team deliverables.
• Maintain and update training materials for the site contract team.
• Serve as a communication liaison between site contracts staff and internal/external customers; provide functional guidance and keep stakeholders informed of contract statuses and pending issues.
• Prepare correspondence as needed.
• Monitor basic financial aspects of the project, including the number of hours/tasks available per contract, and escalate discrepancies in a timely manner.
• 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.
• High level of contract management experience.
• Experience in a contract research organization or pharmaceutical industry essential.
• Strong knowledge of the clinical development process and legal and contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Customer-focused with the 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.
• Excellent written/oral communication, presentation, documentation, interpersonal skills, and strong team orientation.
• Strong organizational skills with proven ability to handle multiple projects.
• Quality-driven approach to managed activities; strong negotiating and problem-solving skills.
• Ability to mentor, lead, 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.

Summary of Site Start-Up / Site ID job family expectations

• Manage and execute site identification processes in accordance with regulations, SOPs, and project requirements.
• Complete and negotiate site confidentiality agreements (CDAs) and site information forms (SIFs) with sites.
• Maintain, review, and report on site performance metrics.
• Serve as a primary point of contact for investigative sites.
• Track completion of site identification for sites.

Compensation & Benefits

Not provided in the job description.

Location

Not provided in the job description.