Talent.com
Contracts Manager, Research and Development, Legal / Senior Site Contracts Leader - FSP
Contracts Manager, Research and Development, Legal / Senior Site Contracts Leader - FSPParexel • Colorado Springs, CO, US
No longer accepting applications
Contracts Manager, Research and Development, Legal / Senior Site Contracts Leader - FSP

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

Parexel • Colorado Springs, CO, US
30+ days ago
Job type
  • Temporary
Job description

Contracts Manager, Research and Development Legal

When 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.

    Create a job alert for this search

    Manager Research Development • Colorado Springs, CO, US

    Related jobs
    Customer Success Manager (Legal AI Solutions)

    Customer Success Manager (Legal AI Solutions)

    Thomson Reuters • Colorado Springs, CO, US
    Full-time
    Thomson Reuters is transforming the legal industry with unmatched legal content, expertise, and innovative AI technology. Thomson Reuters acquired a leading AI startup, Casetext in 2023 and scaled u...Show more
    Last updated: 6 days ago • Promoted
    Contracts Specialist

    Contracts Specialist

    Revvity • Colorado Springs, CO, US
    Full-time
    Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an indust...Show more
    Last updated: 7 days ago • Promoted
    Senior Regulatory Affairs Manager- REMOTE

    Senior Regulatory Affairs Manager- REMOTE

    Revvity • Colorado Springs, CO, US
    Remote
    Full-time
    Senior Regulatory Affairs Manager.Location(s) : US Remote - CT, US Remote - FL, US Remote - GA, US Remote - MA, US Remote - NC, US Remote - NJ, US Remote - VA. Revvity is a developer and provider of ...Show more
    Last updated: 30+ days ago • Promoted
    Resident Relations Manager

    Resident Relations Manager

    Continental Properties • Colorado Springs, CO, United States
    Full-time
    Our Resident Relations Managers perform responsibilities related to business operations, resident satisfaction, leasing activity, financial reporting, rent collection, renewals, and marketing.Commu...Show more
    Last updated: 30+ days ago • Promoted
    Renewables Regulatory NERC Compliance Manager - REMOTE

    Renewables Regulatory NERC Compliance Manager - REMOTE

    ThinkBAC Consulting • Colorado Springs, CO, US
    Remote
    Full-time
    Regulatory Operational Nerc Compliance Manager - Renewables Energy Storage (Bess).Locations : Fully Remote (Anywhere in the USA). This is an opportunity to join an industry leading renewable energy v...Show more
    Last updated: 30+ days ago • Promoted
    Senior Contracts Admin

    Senior Contracts Admin

    Colorado Staffing • Colorado Springs, CO, US
    Full-time
    Support Contracts Management Lead in daily administration of contracts.Create, maintain, and enforce processes for pre-final billing, contract modifications, limitations of funds, and other process...Show more
    Last updated: 5 days ago • Promoted
    Subcontracts Manager

    Subcontracts Manager

    KBR Inc. • Colorado Springs, CO, US
    Full-time
    KBR’s Mission Technology Solutions (MTS) group is looking for a Subcontracts Manager to support a program based in Alice Springs, Australia. This senior role is responsible for strategic oversight, ...Show more
    Last updated: 30+ days ago
    Regulatory Strategy Senior Director - Remote

    Regulatory Strategy Senior Director - Remote

    Thermo Fisher • Colorado Springs, CO, US
    Remote
    Full-time
    Sr Director, Regulatory Strategy.At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - en...Show more
    Last updated: 17 days ago • Promoted
    Senior Site Project Manager

    Senior Site Project Manager

    V2X • Colorado Springs, CO, US
    Permanent
    Overview This position description is subject to change at any time as needed to meet the requirements of the program or company. Working across the globe, V2X builds smart solutions designed to int...Show more
    Last updated: 30+ days ago • Promoted
    Principal Contracts Specialist

    Principal Contracts Specialist

    KBR • Colorado Springs, CO, US
    Full-time
    Principal Contracts Specialist.KBR's National Security Solutions team provides high-end engineering and advanced technology solutions to our customers in the intelligence and national security comm...Show more
    Last updated: 3 days ago • Promoted
    Principal Contracts Specialist (remote)

    Principal Contracts Specialist (remote)

    KBR • Colorado Springs, Colorado, USA
    Remote
    Full-time
    Principal Contracts Specialist (remote).KBRs National Security Solutions team provides high-end engineering and advanced technology solutions to our customers in the intelligence and national secur...Show more
    Last updated: 1 hour ago • Promoted • New!
    Senior Contracts Administrator

    Senior Contracts Administrator

    Clearance Jobs • Colorado Springs, CO, US
    Full-time
    Senior Contracts Administrator.Blackstone Talent Group, an award-winning technology consulting and talent agency, is seeking a Senior Contracts Administrator to join our client's team.As a Senior C...Show more
    Last updated: 30+ days ago • Promoted
    Strategic Partnerships Associate

    Strategic Partnerships Associate

    Sure • Colorado Springs, CO, US
    Full-time
    Strategic Partnerships Associate.Join Sure : Building the Rails of Digital Insurance.Founded in 2015, Sure is the insurance technology leader unlocking the potential of digital insurance.We're build...Show more
    Last updated: 17 days ago • Promoted
    Senior Contracts Administrator

    Senior Contracts Administrator

    LaunchTech • Colorado Springs, CO, US
    Full-time
    Senior Contracts Administrator.Location : Colorado Springs, CO Schriever Space Force Base Clearance Required : Active Secret or higher Travel : Up to 10%. LaunchTech is seeking a Senior Contracts Admi...Show more
    Last updated: 30+ days ago • Promoted
    Contracts Specialist

    Contracts Specialist

    Clearance Jobs • Colorado Springs, CO, US
    Full-time
    Zachary Piper Solutions is seeking a Contracts Specialist to join a US Space Force contract located in Colorado Springs, CO through 100% full onsite presence. The Contracts Specialist will provide s...Show more
    Last updated: 30+ days ago • Promoted
    Engagement Manager (Homeland Layered Defense), Public Sector

    Engagement Manager (Homeland Layered Defense), Public Sector

    Scale AI • Colorado Springs, Colorado, USA
    Full-time
    Scales public sector business is providing the best of American commercial technology and innovation to protect the homeland and meet the moment. As a member of our public sector delivery team you w...Show more
    Last updated: 3 days ago • Promoted
    Regional Partner Services Manager (Remote)

    Regional Partner Services Manager (Remote)

    CrowdStrike • Colorado Springs, CO, US
    Remote
    Full-time
    Regional Service Partner Manager.As a global leader in cybersecurity, CrowdStrike protects the people, processes and technologies that drive modern organizations. Since 2011, our mission hasn't chan...Show more
    Last updated: 30+ days ago • Promoted
    Senior Project Manager- Contractor

    Senior Project Manager- Contractor

    Webstacks • Colorado Springs, CO, US
    Full-time
    Senior Project Manager- Contractor.Webstacks is a high performance website operations and growth marketing agency established in 2020. We have quickly grown into a 45-person company because of our i...Show more
    Last updated: 30+ days ago • Promoted