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

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

Denver StaffingDenver, CO, US
9 hours ago
Job type
  • Temporary
Job description

Contracts Manager, Research And Development Legal

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

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 goals

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 • Denver, CO, US

    Related jobs
    • Promoted
    Travel Physical Therapist

    Travel Physical Therapist

    Critical Connection, incCastle Rock, CO, US
    Full-time
    Critical Connection, inc is seeking a travel Physical Therapist for a travel job in Castle Rock, Colorado.Job Description & Requirements. A Travel Physical Therapist or Local Travel Physical The...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Contractual Deal Strategy, Contracting and Risk Support Senior Manager - National_Office

    Contractual Deal Strategy, Contracting and Risk Support Senior Manager - National_Office

    Denver StaffingDenver, CO, US
    Full-time
    The National Office, a key strategic enabler in our new model, is comprised of professionals with various areas of focus that collectively provide mission critical services to support Deloitte's ov...Show moreLast updated: 9 hours ago
    • Promoted
    • New!
    Licensed Professional Counselor (Therapist) - Elbert, CO

    Licensed Professional Counselor (Therapist) - Elbert, CO

    LifeStance HealthElbert, CO, US
    Full-time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...Show moreLast updated: 22 hours ago
    • Promoted
    Senior Manager - Client Development, Capital One Ad Solutions (Remote)

    Senior Manager - Client Development, Capital One Ad Solutions (Remote)

    Colorado StaffingDenver, CO, US
    Remote
    Full-time +1
    Senior Manager - Client Development.Capital One Ad Solutions is looking for a Senior Strategic Client Manager to join the Partnerships Team. You'll be responsible for partnering with our top merchan...Show moreLast updated: 2 days ago
    • Promoted
    Reliability Engineer

    Reliability Engineer

    Golden AluminumFort Lupton, CO, US
    Full-time
    We are a continuous casting aluminum rolling mill who established operations in 1984 and located in Fort Lupton Colorado, 35 miles north of downtown Denver. We care about our environment, our people...Show moreLast updated: 30+ days ago
    • Promoted
    Training and Development Intern

    Training and Development Intern

    Golden AluminumFort Lupton, CO, US
    Full-time
    We are a continuous casting aluminum rolling mill who established operations in 1984 and located in Fort Lupton Colorado, 35 miles north of downtown Denver. We care about our environment, our people...Show moreLast updated: 6 days ago
    • Promoted
    Pediatric Occupational Therapist

    Pediatric Occupational Therapist

    Angels of Care Pediatric Home HealthBrighton, CO, US
    Full-time +1
    At Angels of Care Pediatric Home Health, we believe in more than just therapy — we believe in building a community where clinicians are supported, children are empowered, and families are nev...Show moreLast updated: 2 days ago
    • Promoted
    • New!
    Licensed Marriage & Family Therapist (Mental Health Therapist) - Lochbuie, CO

    Licensed Marriage & Family Therapist (Mental Health Therapist) - Lochbuie, CO

    LifeStance HealthLochbuie, CO, US
    Full-time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...Show moreLast updated: 22 hours ago
    • Promoted
    Travel Physical Therapist

    Travel Physical Therapist

    Skyline Med Staff AlliedGolden, CO, US
    Full-time
    Skyline Med Staff Allied is seeking a travel Physical Therapist for a travel job in Golden, Colorado.Job Description & Requirements. Join the Top- Rated Travel Healthcare Team!.Skyline Med Staff...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Physical Therapist

    Travel Physical Therapist

    Arrow Healthcare StaffingCastle Rock, CO, US
    Full-time
    Arrow Healthcare Staffing is seeking a travel Physical Therapist for a travel job in Castle Rock, Colorado.Job Description & Requirements. Arrow Healthcare Staffing Job ID #17430714.Pay package ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Construction Project Manager

    Senior Construction Project Manager

    Murphy CompanyBrighton, CO, US
    Full-time
    Senior Construction Project Manager.Since 1907, Murphy Company has been a leading mechanical contractor in the St.Louis and Denver markets that provides its professionals the environment, opportuni...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Project Manager - Residential Painting

    Project Manager - Residential Painting

    Elk Horn PaintingCastle Rock, CO, US
    Full-time
    Job Title : Project Manager - Residential Painting.I’m Hunter, the CEO of Elk Horn Painting - where we hire TOP performers. And we understand that the best people out there are looking for the ...Show moreLast updated: 19 hours ago
    • Promoted
    Principal Change Management Lead – Systems Engineering & Proposal Support

    Principal Change Management Lead – Systems Engineering & Proposal Support

    RaytheonWestminster, Colorado, US
    Full-time +1
    Do not wait to apply after reading this description a high application volume is expected for this opportunity.CO102 : 16800 E Centretech Pkwy,Aurora 16800 East Centretech Pkwy Building S75, Aurora,...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Client Services, Channel Partners

    Senior Director, Client Services, Channel Partners

    The Trade DeskDenver, CO, United States
    Full-time
    A strategic, enterprise-minded leader who brings clarity, operational rigor, and accountability to a high-growth environment. Someone who balances client success, team development, and commercial ou...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Licensed Marriage & Family Therapist (Mental Health Therapist) - Brighton, CO

    Licensed Marriage & Family Therapist (Mental Health Therapist) - Brighton, CO

    LifeStance HealthBrighton, CO, US
    Full-time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...Show moreLast updated: 22 hours ago
    • Promoted
    Regulatory Affairs Professional (Open Rank : Intermediate - Senior)

    Regulatory Affairs Professional (Open Rank : Intermediate - Senior)

    University of Colorado Anschutz Medical CampusAurora, CO, United States
    Full-time
    Colorado Anschutz Medical Campus.Regulatory Affairs Professional (Open Rank : Intermediate - Senior).The Department of Neurology has an immediate opening for a full-time Regulatory Affairs Professio...Show moreLast updated: 15 days ago
    • Promoted
    Senior Manager - Contractual Deal Strategy, Contracting and Risk Support (Global Capability Center (GCC) Operate / Managed Services / Staff Augmentation)-National_Office

    Senior Manager - Contractual Deal Strategy, Contracting and Risk Support (Global Capability Center (GCC) Operate / Managed Services / Staff Augmentation)-National_Office

    Denver StaffingDenver, CO, US
    Full-time
    The National Office, a key strategic enabler in our new model, is comprised of professionals with various areas of focus that collectively provide mission critical services to support Deloittes ove...Show moreLast updated: 7 days ago
    • Promoted
    Senior Manager - Client Development, Capital One Ad Solutions (Remote)

    Senior Manager - Client Development, Capital One Ad Solutions (Remote)

    Denver StaffingDenver, CO, US
    Remote
    Full-time +1
    Senior Manager - Client Development.Capital One Ad Solutions is looking for a Senior Strategic Client Manager to join the Partnerships Team. You'll be responsible for partnering with our top merchan...Show moreLast updated: 2 days ago