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

Parexel • Montpelier, VT • 5h ago

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

LI-CF1

LI-REMOTE

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.

Parexel

Go to Apply

Share this job

Similar Jobs

Senior Analyst, Finance Operations - Contracting

Cardinal Health • Montpelier, VT • 8h ago

Legal & Paralegal

What Finance Operations contributes to Cardinal Health Finance oversees the accounting, tax, financial plans and policies of the organization, establishes and maintains fiscal controls, prepares and interprets financial...

8h ago

Go to Apply

Mechanical Engineer 5(Industrial/Process)

CDM Smith • Montpelier, VT • 12h ago

Legal & Paralegal

43061BR Requisition ID: 43061BR Business Unit: IND Job Description: With general direction, creates engineering designs including: Reviews draft designs for compliance with federal, state and local regulations and signs...

12h ago

Go to Apply

Mechanical Engineer 5(Industrial/Process)

CDM Smith • Barre, VT • 12h ago

Legal & Paralegal

12h ago

Go to Apply

Mechanical Engineer 5(Industrial/Process)

CDM Smith • Montpelier, VT • 12h ago

Legal & Paralegal

12h ago

Go to Apply

Industrial Technical Services Representative (Pacific Time)

WM • Montpelier, VT • 4d ago

Legal & Paralegal

WM, a Fortune 250 company, is the leading provider of comprehensive waste and environmental services in North America. We are strongly committed to a foundation of operating excellence, professionalism and financial stre...

4d ago

Go to Apply

AOT Contracts Specialist III

State of Vermont • Barre, VT • 6d ago

Legal & Paralegal

This job was posted by https://www.vermontjoblink.com : For more information, please see: https://www.vermontjoblink.com/jobs/1311482 Overview The Agency of Transportation\'s Contract Administration Bureau is seeking a m...

6d ago

Go to Apply

AOT Contracts Specialist II

State of Vermont • Barre, VT • 6d ago

Legal & Paralegal

This job was posted by https://www.vermontjoblink.com : For more information, please see: https://www.vermontjoblink.com/jobs/1311480 Overview The Agency of Transportation\'s Contract Administration Bureau is seeking a m...

6d ago

Go to Apply

AOT Contracts Specialist I

State of Vermont • Barre, VT • 6d ago

Legal & Paralegal

This job was posted by https://www.vermontjoblink.com : For more information, please see: https://www.vermontjoblink.com/jobs/1311477 Overview The Agency of Transportation\'s Contract Administration Bureau is seeking a m...

6d ago

Go to Apply

IT Contract and Procurement Analyst III

State of Vermont • Montpelier, VT • 1w ago

Legal & Paralegal

This job was posted by https://www.vermontjoblink.com : For more information, please see: https://www.vermontjoblink.com/jobs/1311177 Overview The Agency of Digital Services is a team of information technology profession...

1w ago

Go to Apply

Bankruptcy Ledger Specialist

Carrington • Montpelier, VT • 1w ago

Legal & Paralegal

Come join our amazing team and work remote from home! Bankruptcy Ledger Experience Required to be Considered! The Bankruptcy Ledger Specialist will be responsible for completing and monitoring ledgers through the Bankrup...

1w ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.