Site Contract Lead, FSP

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

📋 Description

• Develop, maintain, and refresh training materials for the site contracts lead team and site contract negotiators.

• Act as a subject matter expert for global site contracting matters and serve as an escalation point for internal clients.

• Manage negotiations of clinical study agreements and ensure the finalization and execution of documents.

• Supervise the status of contract and budget negotiations while handling escalations.

• Provide guidance to study teams and Sponsor stakeholders on industry trends, standards, risks, and mitigation strategies.

• Serve as the primary subject matter expert for CTA components on assigned studies and offer advice on resolving issues.

• Strategize contract execution plans and predict timelines for site-specific contract execution.

• Facilitate communication among study stakeholders and global site contract and budget negotiators.

• Create site contractual templates, payment terms, negotiation parameters, and processes.

• Foster collaborative relationships with Sponsors and internal project teams.

• Recognize contractual, budgetary, and process risks while providing effective solutions.

• Generate and maintain document status reports, updating departmental tools, systems, and team members as necessary.

• Work in collaboration with legal, finance, and clinical operations departments.

• Lead discussions regarding fair market value of investigator budgets and payment terms.

• Identify best practices, analyze root causes, and propose solutions.

• Train and mentor junior staff on standard operating procedures, processes, tools, and templates.

• Assist business units and the organization through help desk and other issue-resolution channels.

• Spearhead internal training and process improvement initiatives as required.

• Participate in business development presentations as a subject matter expert.

• Undertake other work-related responsibilities as assigned.

• Occasional travel may be required, up to 25%.

⛳️ Requirements

• Bachelor’s degree or higher.

• A legal background is essential.

• Extensive experience in the CRO/pharmaceutical industry along with relevant clinical trial knowledge or site start-up experience.

• Comprehensive understanding of applicable regulations, drug development, and clinical project management protocols.

• Excellent presentation, documentation, and interpersonal skills.

• Proficient in MS Office, MS Project, Outlook, and internet applications.

• Capability to manage multiple tasks and meet deadlines in a fast-paced environment.

• Above-average attention to detail.

• Strong oral and written communication skills.

• Ability to work independently to meet deadlines.

• Demonstrated leadership skills.

• Capacity to teach and mentor team members.

• Ability to coach employees to achieve performance goals.

• Solid background in issue resolution, fulfilling customer deliverables, and implementing best practices at the organizational or customer portfolio level.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition programs.

• Comprehensive total rewards program.

• Emphasis on a Total Self culture.

• Commitment to diversity and an inclusive workplace.

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

• Various career paths and employment opportunities available.