Site Contract Specialist II

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

📋 Description

• Oversee contract management procedures for protocols, informed consent, institutional, investigator, vendor, consultant, and customer agreements at the project level.

• Lead multi-country projects, with guidance, that involve negotiating and preparing contracts, budgets, and associated clinical-trial documentation.

• Assist in the agreement concerning country-specific template contracts and budgets.

• Create site-specific contracts derived from country templates.

• Aid in the submission and negotiation processes for proposed site contracts and budgets.

• Conduct quality control, facilitate the execution of clinical trial agreements, and archive documents while capturing metadata.

• Evaluate contracts for completeness and accuracy, making necessary documentation corrections.

• Support business development and act as a representative for site contracts/Site Start-Up during internal and client meetings.

• Manage ongoing contract-related issues and follow up on unresolved items.

• Produce amended contract and budget documents while optimizing contract, proposal, and internal processes.

• Monitor country/site contracting milestones against projected timelines in the SSU tracking system.

• Collaborate with legal, finance, and clinical operations teams on legal and budgetary matters.

• Ensure contract execution by the company's authorized signatories.

• Maintain contract templates, site-specific files, and relevant databases.

• Train and mentor junior staff on Standard Operating Procedures (SOPs) and guarantee the quality of team outputs.

• Keep training materials for the site contract team current and relevant.

• Serve as a communication bridge between site contracts personnel and both internal and external clients.

• Provide advice and communicate on contract statuses and outstanding issues.

• Draft correspondence as needed.

• Monitor fundamental project financial elements and contract hours/tasks, escalating any discrepancies.

• Review and adhere to SOPs and Work Instructions, maintain training records, and ensure compliance with timesheets.

⛳️ Requirements

• Bachelor's degree in Business Administration, Public Administration, Public Health, or a related field, or an equivalent combination of education and experience.

• Advanced degree is preferred.

• Extensive experience in contract management.

• Essential experience in a contract research organization or the pharmaceutical industry.

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

• Proficient in Microsoft Office Suite.

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

• Sound understanding of clinical protocols and associated study specifications.

• Excellent grasp of clinical trial start-up procedures.

• Experience in project management within a dynamic environment.

• Proficient vendor management skills.

• Strong negotiation capabilities.

• Exceptional problem-solving skills.

• Ability to mentor, lead, and inspire junior staff.

• Capacity to provide constructive feedback and guidance to colleagues.

• Capability to contribute to training and quality assurance plans within SSU and update SOPs/Work Instructions.

• Outstanding written and oral communication, presentation, documentation, interpersonal, and team-oriented skills.

• Excellent organizational skills with the ability to manage multiple projects simultaneously.

• Committed to quality in all managed activities.

• Customer-focused, adept at managing challenging priorities while remaining flexible and adaptable in high-pressure situations.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive rewards program.

• Inclusive workplace culture.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Diverse career paths and job opportunities available.