Site Contracts Lead

This is a fully remote position, open to applicants in Taiwan, +1 more country.

📋 Description

• Manage the negotiation process for clinical study agreements at the study level.

• Facilitate the finalization and execution of CTA documents, encompassing contractual language and terms, financial attachments, and investigator grant budgets.

• Oversee the status of contract and budget negotiations.

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

• Serve as the primary subject matter expert for CTA components related to assigned studies.

• Provide guidance to stakeholders on resolving issues.

• Develop a strategy for contract execution and project site-specific timelines for contractual execution.

• Align the CTA strategy with the internal study team and overall plans for study initiation.

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

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

• Participate in regular study meetings and calls.

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

• Collaborate with sponsors to ensure site contract templates are in line with global program strategies.

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

• Ensure that appropriate documentation is maintained.

• Work collaboratively with legal, finance, and clinical operations departments.

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

• Assist business units and the organization via help desk and other defined pathways.

• Carry out additional 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 background in the CRO/pharmaceutical sector with relevant clinical trial experience (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience.

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

• Strong presentation, documentation, and interpersonal skills.

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

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

• Strong attention to detail.

• Excellent oral and written communication skills.

• Capability to work independently to meet deadlines.

• Demonstrated leadership abilities.

• Experience in teaching and mentoring team members.

• Some travel may be necessary, up to 25%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Recognition from peers.

• Comprehensive total rewards program.

• Commitment to an inclusive culture.

• Reasonable accommodations available when appropriate.