United States onlyWhen our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Job Summary:
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
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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