Senior Site Contracts Specialist, Malaysia

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

📋 Description

• Oversee multi-country initiatives, which include negotiating and drafting contracts, budgets, and associated documents for industry-sponsored clinical trials.

• Create and assess site-specific contracts derived from country clinical trial agreement templates.

• Present proposed CTAs and investigator budgets for site assessment.

• Negotiate budgets and contracts with sites, the Site Contracts Service Centre, SSUL, and sponsors.

• Conduct quality control, facilitate CTA execution, organize document archiving, and capture metadata.

• Manage contract administration processes encompassing protocol, informed consent, institution, investigator, vendor, consultant, and customer agreements.

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

• Collaborate with the Site Contract Service Center and Legal to ensure site contracts align with sponsor master service agreement terms.

• Partner with SSU lead, Clinical Operations, and Finance to confirm departmental budget allocations and backlogs.

• Recognize contract and process risks, offer solutions, and escalate deviations as necessary.

• Assist in business development and represent site contracts/SSU during internal or customer meetings.

• Monitor country/site contracting timelines and milestone advancement in the SSU tracking system.

• Work alongside legal, finance, and clinical operations teams on legal and budgetary matters.

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

• Act as the communication liaison regarding contract statuses and outstanding issues.

• Train and mentor junior staff while keeping training materials updated.

• Facilitate contract execution by company signatories.

• Track project financial elements and contract hours/tasks, addressing discrepancies as needed.

• Review and adhere to SOPs and WIs, ensuring timesheet compliance.

⛳️ 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.

• Moderate experience in contract management, particularly within a contract research organization or pharmaceutical sector.

• Management experience is preferred.

• In-depth knowledge of the clinical development process and legal and contracting standards.

• Proficient computer skills in the Microsoft Office Suite.

• Customer-oriented with the ability to manage competing priorities while remaining flexible and adaptable in stressful circumstances.

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

• Good understanding of clinical protocols and related study specifications.

• Excellent knowledge of clinical trial start-up procedures.

• Project management experience in a dynamic environment.

• Effective vendor management capabilities.

• Exceptional organizational skills with a proven track record of handling multiple projects simultaneously.

• Outstanding communication, presentation, and interpersonal abilities.

• Quality-focused in all managed activities.

• Strong negotiation skills.

• Excellent problem-solving capabilities.

• Ability to mentor and motivate junior team members.

• Capability to provide constructive feedback and guidance to colleagues.

• Ability to contribute to a training and Quality Assurance plan within SSU and update SOPs/WIs accordingly.

• Ability to adhere to SOPs, WIs, training documentation, and timesheet regulations.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations, when appropriate, for employees or applicants with disabilities.