Parexel · 16 hours ago
Contracts Manager, Research and Development, Legal / Senior Site Contracts Leader - FSP
United States
Contract
Remote
Senior Level
5+ years expParexel is a leading global biopharmaceutical services organization, and they are seeking a Contracts Manager to support clinical trials through effective contract management. The role involves negotiating and reviewing various agreements, maintaining compliance with standards, and collaborating with cross-functional teams to ensure efficient contract execution.
Pharmaceuticals
Responsibilities
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
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
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
Qualification
Required
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
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
Preferred
ICF review experience is preferred
Company
Parexel
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.
10001+ employees
H1B Sponsorship
Parexel has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (33)
2024 (46)
2023 (41)
2022 (51)
2021 (54)
2020 (33)
Funding
Current Stage
Late StageLeadership Team
Amy France
SVP, CFO - Consulting & Commercial
Carlos Daniel Garcia
VP Chief Financial Officer - Medical Scientific Services Business Unit
Recent News
2024-04-27
2024-04-07
Company data provided by crunchbase