Contracts Manager, Research and Development, Legal / Senior Site Contracts Leader - FSP

The Contracts Manager, Research and Development Legal will be responsible for providing contract management to support clinical trials.

Key Accountabilities:

Contract Negotiations and Reviews

• Review and negotiate Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and Informed Consent Forms (ICFs), either directly or as escalated by Contract Research Organizations (CROs)

• Identify and escalate contract terms to appropriate contract owners, attorneys, and other appropriate stakeholders, in a timely manner

• Build strong working relationships with CRO contracting staff (including contracting staff at medical institutions) to facilitate quick contract executions and conflict resolutions ensuring efficient conduct of clinical trials Track and drive contracts to execution, including identifying remaining contracting issues, identifying appropriate stakeholders to reach decisions and convening meetings to drive efficient decision-making

•  Identify and effectively communicate priorities and urgencies to applicable stakeholders

• Participate in cross-functional teams to ensure contract executions and strategies are achieving targeted goal

Contract Administration / Operational Management

• Serve as an expert in client Contract Management System (CMS) and processes

• Work closely with Legal Operations and the CMS teams to ensure contracts are properly managed in the system and develop enhancements, improvements and updates

• Partner with Legal and other colleagues to address and solve day-to-day contracting issues and proactively troubleshoot and implement short-term and long-term contract improvements and efficiencies

• Support and manage contract templates and guidelines, as requested; track negotiated terms across agreements and identify potential updates to contracting guidelines

• Propose updated contracting guidelines, as needed

Compliance with Parexel Standards

• Complies with required training curriculum

• Completes timesheets accurately and timely as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• General understanding of applicable laws and regulations as well as legal risks that might impact research and development of a commercial-stage biotech company (including confidentiality, intellectual property, anti-kickback/anti-bribery laws, FDA regulations, and privacy laws)

• Strong written, oral communication, interpersonal, and organizational skills

• Ability to work independently as well as in a team environment  

• Ability to effectively prioritize workload and communicate priorities

• Ability to work and adapt in a complex and dynamic organization handling multi-faceted projects with tight timelines

• Ability to interact effectively and productively with all levels within an organization in a calm and professional manner

• Motivated to work in a fast-paced environment

• Detail oriented

Knowledge and Experience:

• Minimum 5 years of site contracting experience in a CRO or pharma setting

• Experience negotiating CDAs, CTAs, and ICFs, either in a pharmaceutical/biotech company or CRO

• Experience negotiating with a Contract Management System (CMS) required

• ICF review experience is preferred

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