Site Contracts Lead

Posted Oct 23

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

📋 Description

• Oversee the negotiation process of clinical study agreements at the study level.

• Drive the finalization and execution of Clinical Trial Agreements (CTA), including the contractual language, terms, financial attachments, and budgets for investigators.

• Collaborate with a global team of site contract and budget negotiators.

• Provide oversight on the status of contract and budget negotiations.

• Manage the escalation of budgetary and contractual requests that are outside standard parameters to the sponsor decision-makers.

• Offer consultation and serve as the first-line subject matter expert on CTA elements.

• Advise stakeholders on issue resolution for the studies assigned to you.

• Plan the strategy for contract execution and forecast site-specific timelines for contractual execution.

• Coordinate with internal study team stakeholders to align CTA strategy with study start-up plans.

• Manage the expectations of both internal and sponsor study teams concerning global CTA negotiations.

• Facilitate communications between study stakeholders and global site contract and budget negotiators.

• Participate in regular study meetings.

• Prepare templates for site contracts, payment terms, negotiation parameters at the study level, and associated processes.

• Build collaborative relationships with sponsors to ensure site contractual templates align with the global program strategy.

• Create and maintain document status reports and update department tools, systems, and team members accordingly.

• Maintain accurate and appropriate documentation.

• Collaborate with the legal, finance, and clinical operations departments.

• Communicate and clarify legal and budgetary issues effectively.

• Manage discussions pertaining to fair market value for investigator budgets and payment terms.

• Support business units and the organization through help desk services and other defined pathways.

• Execute other work-related duties as assigned.


⛳️ Requirements

• Bachelor's degree in life sciences, a health-related field, or an equivalent combination of education and experience.

• Preferred experience within a CRO or pharmaceutical industry.

• Relevant clinical trial experience, including roles such as Study Coordinator, Clinical Research Associate (CRA), Pharmacy, Nursing, or Healthcare Administration.

• Site start-up experience is preferred.

• Comprehensive knowledge of applicable regulations, drug development, and procedures in clinical project management.

• Strong presentation, documentation, and interpersonal skills.

• Proficient in Microsoft Office (Word, Excel, and PowerPoint), MS Project, Outlook, and internet applications.

• Capability to manage multiple tasks and meet deadlines while delivering high-quality work in a dynamic setting.

• Attention to detail is crucial.

• Effective oral and written communication skills.

• Ability to work independently and meet deadlines.

• Strong leadership capabilities.

• Ability to teach and mentor team members.

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

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


🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive culture within the organization.

• Reasonable accommodations provided when appropriate.

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