Sr. Site Contract Specialist

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

📋 Description

• Oversees all processes related to contract management, ensuring coordination with relevant protocols, informed consent, institutional, investigator, vendor, consultant, and customer agreement documents at a project level.

• May manage (with supervision) multi-country projects, which includes negotiating and drafting contracts, budgets, and related documents for participation in industry-sponsored clinical trials.

• Assists SSUL in finalizing country template contracts and budgets.

• Generates site-specific contracts based on the country template.

• Aids in the submission of proposed contracts and budgets for sites.

• Supports negotiations of budgets and contracts with sites 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.

• Examines contracts for completeness and accuracy, ensuring that necessary corrections are made and documented appropriately.

• Provides assistance to business development and represents site contracts/Site Start-Up (SSU) in both internal and customer meetings.

• Collaborates with Contract Managers and team members on the active management of ongoing contract issues; follows up on all outstanding contract matters.

• Aids in creating amended contract and/or budget documents as necessary, prepares contract management documentation for projects, and seeks to streamline contract/proposal or internal processes; introduces innovative ideas and solutions.

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

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

• Facilitates the signing of contracts by company representatives.

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

• Trains and mentors junior staff on departmental Standard Operating Procedures (SOPs) and ensures quality in team deliverables.

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

• Acts as a communication bridge between site contracts staff and both internal and external customers.

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

• Drafts correspondence as needed.

• Monitors basic financial elements of the project and the availability of hours/tasks per contract, promptly escalating any discrepancies.

• Reviews and adheres to Standard Operating Procedures (SOPs) and Work Instructions (WIs) punctually, maintains updated training records, and ensures compliance with timesheets.

⛳️ Requirements

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

• An advanced degree is preferred.

• Extensive experience in contracts management is required.

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

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

• Proficient computer skills in Microsoft Office Suite.

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

• Solid understanding of clinical protocols and related study specifications.

• Profound knowledge of clinical trial start-up processes.

• Project management experience in a fast-paced environment.

• Effective vendor management skills.

• Exceptional written/oral communication, presentation, documentation, and interpersonal skills, with a strong emphasis on teamwork.

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

• Quality-focused in all managed activities.

• Excellent negotiation skills.

• Strong problem-solving abilities.

• Capable of mentoring, leading, and motivating junior staff members.

• Demonstrates an ability to provide constructive feedback and guidance to colleagues.

• Contributes to training and Quality Assurance plans within SSU and updates SOPs/WIs as needed.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive rewards program.