Site Contracts Specialist II – Multiple Sponsors

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversees all aspects of contract management, including coordination with pertinent protocol, informed consent, institutional, investigator, vendor, consultant, and customer agreement documents at the project level.

• May take the lead (under supervision) on multi-country projects, including the negotiation and preparation of contracts, budgets, and related documents for participation in industry-sponsored clinical trials.

• Assists SSUL in reaching an agreement on the country template contract and budget.

• Generates site-specific contracts derived from the country template.

• Supports the submission process for proposed contracts and budgets for sites.

• Aids in negotiating the budget and contract with the site through the Site Contracts Service Centre and SSUL with the Sponsor until all issues are resolved.

• Conducts quality control and organizes the execution of CTAs, as well as the archiving of documents into repositories and capturing of metadata.

• Reviews contracts for completeness and accuracy, ensuring that any corrections are made and documented appropriately.

• Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.

• Collaborates with Contract Managers and team members to actively manage ongoing contract issues, following up on all outstanding matters.

• Assists in creating amended contract and/or budget documents as necessary, preparing documentation for contract management projects, and streamlining contract/proposal or internal processes; introduces innovative ideas and solutions.

• Works within the projected country/site contracting timelines, ensuring compliance and tracking milestone progress in the designated SSU tracking system in real time.

• Collaborates with internal and external legal, finance, and clinical operations departments, effectively communicating and clarifying legal and budgetary issues.

• Facilitates the contract execution process by company signatories.

• Maintains contract templates and site-specific files and databases.

• Trains and mentors junior staff members on departmental Standard Operating Procedures (SOPs), ensuring the quality of team deliverables.

• Keeps training materials for the site contract team current and updated.

• Acts as a communication liaison between site contracts personnel and internal and external clients.

• Provides functional guidance and keeps internal and external teams informed about all contract statuses or pending issues.

• Prepares necessary correspondence.

• Monitors basic financial aspects of the project, including available hours/tasks per contract, and escalates discrepancies promptly.

• Reviews and adheres to Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, ensuring that training records are updated accordingly and timesheet compliance is maintained.

⛳️ 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.

• Extensive experience in contracts management.

• Experience in a contract research organization or pharmaceutical industry is essential.

• Strong understanding of the clinical development process and legal and contracting parameters.

• Proficient in Microsoft Office Suite.

• Customer-focused, with the ability to manage competing priorities while remaining flexible and adaptable in stressful situations.

• Excellent understanding of the clinical trial process across Phases II-IV and ICH GCP.

• Solid comprehension of clinical protocols and associated study specifications.

• Thorough understanding of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Strong vendor management capabilities.

• Exceptional written and oral communication, presentation, documentation, and interpersonal skills, along with a strong team-oriented approach.

• Excellent organizational skills with a proven ability to manage multiple projects and communicate effectively.

• Quality-driven in all activities managed.

• Strong negotiating and problem-solving skills.

• Ability to mentor, lead, and motivate junior staff members.

• Demonstrates the ability to provide constructive feedback and guidance to peers.

• Contributes to a training and quality assurance plan within SSU and updates SOPs/WI as needed.

🏝️ Benefits

• We are dedicated to the development of our staff through career advancement and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can truly be yourself.