Sr Site Contracts Lead/高级临床合同主管

FSP Top Global Pharma - 可全国任何城市homebased
-2年以上SSU Lead/Site Contracts Lead相关经验，5年以上SSU合同谈判经验
-Legal背景，主要负责SSU Legal Escalation point
-Fluent in English(全英文面试)
Job Summary
Manages administration and functional processes for site contracts and SSU-related legal matters that support awarded projects. Provides support to help resolve global site contracting and legal issues arising from clinical trial set up activities. Escalation point within the Company for internal customers to seek assistance. Supports BU and organization through help desk and other defined pathways to resolve and deescalate issues. Proactively manages the workflow of legal requests from internal customers and respond with the service level timelines by providing subject matter expertise and guidance on clinical trial agreements, powers of attorney, letters of authorization, confidentiality disclosure agreements, service agreements, ancillary medical services contracts (radiology, pharmacy, national coordinator, laboratory, equipment, start-up agreements) and any other agreements, requests and/or documentation that may be required for the conduct and management of a clinical trial.
Core Responsibilities
• Establishes, maintains and updates training material for BU on various aspects of site contracting process from country requirements, sponsor processes to other subject matter areas that affect site contracting process.
• Develops and shares expertise regarding sponsor processes, local country/site investigator contracts requirements within the team and BU.
• Serve as mentor to less experienced members of the team.
• Actively participates in higher level discussions about overall company goals, functional objectives in the BU, and specific project aims.
• Subject matter expert equipped to help resolve global site contracting and legal issues arising from clinical trial set up activities.
• Develop and maintain of Company’s suite of investigator contract templates, confidentiality agreements, letter of authorization and improve associated processes and procedures around this documentation.
• Proposes contracting solutions to issues that may arise during a project or contract life cycle, to enhance negotiation strategy and ensure deliverables are met.
• Establishes site contract project strategies around language parameters to reflect sponsor's master service agreement terms and required processes.
• Identifies possible contract or process operational risk and proactively works to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.
• Serves as a resource to business development and represents site contracts at internal or customer meetings and input as required into site contracting RFPs, as required.
• Ensures site contract templates are drafted taking into consideration key operational aspects indicated in the relevant operational documents (e.g. protocol, pre-study visit report, etc.), as well as in the customer agreement documents at a project and organizational level.
• Establishes strong working relationships and collaboration with Sponsor to ensure site contract templates fit into the global strategy set for the program.
• Responsible for drafting, negotiating with Sponsor legal department or contract representatives and harmonizing site contract templates, site contract language, fallback templates and parameters, within Company processes and works closely with Company’s corporate Legal and other internal stakeholders to obtain any cross-functional input needed. Identifies risk areas for Company arising form site contracts and offer mitigation solutions to protect Company.
• Serves as main point of contact for the sponsor legal to legal escalations to obtain timely approval of changes outside of approved negotiation and provide solutions to broker execution of contract-related documents for a given study,
• Generates site contract documents of all variations, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Supports existing Company initiatives to streamline site contract negotiations. Introduce new initiatives to facilitate better contract negotiations and solutions and lead working groups to develop and improve aspects of site contracting strategy, policy or documentation.
• Creates and maintains document status reports and updates department team members on a regular basis; ensures appropriate documentation is maintained for all exceptions.
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Represents the Company at professional meetings or seminars.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Qualifications
• Legal degree or equivalent required.
• Extensive experience in a CRO and related contract management, legal and/or site start-up experience.
• Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. Strong presentation, documentation, and interpersonal skills.
• Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, outlook, and Internet.
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
• Strong leadership skills; ability to teach/mentor team members. Ability to coach employees to reach performance objectives. Strong background in issue resolution, meeting customer deliverables and driving best practices at organization or customer portfolio level