Site Contracts Specialist, CRO/Pharma Experience

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

📋 Description

• May oversee multi-country projects, including negotiating and preparing contracts, budgets, and associated documents for involvement in industry-sponsored clinical trials.

• Creates site-specific contracts derived from the country clinical trial agreement (CTA) template.

• Reviews and assumes ownership of site-specific contracts originating from the country template.

• Submits proposed CTA and investigator budgets for site evaluation.

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

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

• Evaluates contracts for completeness and precision, ensuring that any necessary corrections are made and properly documented.

• Manages all contract administration processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at the project level.

• Generates amended contract and/or budget documents as needed, preparing contract management documentation for projects, and optimizing the contract/proposal or internal processes; introduces innovative ideas and solutions.

• Collaborates closely with the Site Contract Service Center and Legal to align site contracts with the sponsor's master service agreement terms.

• Works in partnership with SSU lead, Clinical Operations, and Finance to validate the input of departmental budgets and associated backlog.

• Identifies potential operational risks related to contracts or processes and proactively collaborates with the team to propose solutions.

• Establishes strong working relationships with the SSU lead, customers, and internal project teams.

• Reports deviations to department leadership and/or the Site Contract Service Center and/or Legal Department.

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

• Adheres to forecasted country/site contracting timelines, ensuring compliance and tracking milestone progress in the agreed-upon SSU tracking system in real-time.

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

• Maintains and actively contributes to the review and development of contract templates, budget templates, and site-specific files and databases.

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

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

• Prepares necessary correspondence.

• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures the quality of team outputs.

• Updates and maintains training materials for the site contract team.

• Actively engages in higher-level discussions regarding overall company objectives, departmental goals, and specific project targets.

• Facilitates the execution of contracts by company signatories.

• Monitors fundamental financial aspects of the project and the hours/tasks available per contract; escalates discrepancies promptly.

• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly, and ensures compliance with timesheets.

⛳️ Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, a related field, or an equivalent combination of education and experience.

• Advanced degree preferred.

• Moderate experience in contract management, ideally within a contract research organization or pharmaceutical industry.

• Management experience is preferred.

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

• Good knowledge of clinical protocols and related study specifications.

• Strong grasp of clinical trial start-up processes.

• Project management experience in a fast-paced setting.

• Competent vendor management skills.

• Exceptional organizational skills with a proven ability to manage multiple projects.

• Excellent communication, presentation, and interpersonal skills.

• Quality-driven in all managed activities.

• Strong negotiation abilities.

• Excellent problem-solving skills.

• Capable of mentoring and motivating junior staff.

• Demonstrated ability to provide constructive feedback and guidance to peers.

• Contributes to a training and quality assurance plan within SSU and updates SOPs/WIs.

🏝️ Benefits

• We are dedicated to developing our people through career advancement and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive total rewards program.

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