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Investigator Contract Lead 1

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Pfizer

1mo ago

  • Job
    Full-time
    Senior Level
  • Legal
    Business, Operations & Strategy
  • Rome
  • Quick Apply

AI generated summary

  • You need 5+ years in clinical development, experience with budgets and contracting, strong communication skills, and a JD or equivalent with clinical trial agreement expertise.
  • You will negotiate clinical trial agreements, manage site budgets, develop relationships with key sites, address contracting issues, and collaborate with various divisions to improve processes.

Requirements

  • 5+ years of experience in clinical development operations or clinical trial outsourcing and a bachelor’s degree.
  • Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities.
  • Balance of general business, compliance, finance, legal, and drug development experience.
  • Precise communications and presentation skills.
  • Ability to plan, identify and mitigate risks to site contacting timelines.
  • Demonstrated ability to lead by influence rather than positional power to accomplish critical deliverables.
  • Demonstrated success in working in a highly matrix-based organization.
  • 2+ years of experience in clinical development operations or clinical trial outsourcing and a US Juris Doctorate or equivalent legal degree.
  • Experience in drafting and negotiating of Clinical Trial Agreements with clinical trial sites in a global operation.

Responsibilities

  • Exercise good judgment in balancing the risks for Pfizer in making budget and contractual decisions against the impacts to Pfizer clinical trial timelines.
  • Follow GPD processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials.
  • Work with partners to develop and oversee the global site budget process.
  • Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters.
  • Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface.
  • Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies.
  • Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space.
  • Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space.
  • Has knowledge of the principles, concepts and theories in applicable business discipline.
  • Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements.
  • Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline.
  • Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to the achievement of business objectives at GPD or WSR Functional Line level – e.g., WSR Worldwide Safety, WSR Worldwide Regulatory Operations, GPD Clinical Development & Operations, etc.

FAQs

What is the main responsibility of an Investigator Contracts Lead?

The main responsibility of an Investigator Contracts Lead is to manage direct site-facing contract and budget negotiations with clinical investigator sites, oversee other contracting professionals, manage the Per-Subject Cost process, and ensure timely site contracting in collaboration with other teams.

What qualifications are required for this position?

The basic qualifications include 5+ years of experience in clinical development operations or clinical trial outsourcing, a bachelor’s degree, experience with clinical study budgets and contracting negotiation, and strong communication and planning skills.

Are there preferred qualifications for this role?

Yes, preferred qualifications include 2+ years of experience in clinical development operations or clinical trial outsourcing, a US Juris Doctorate or equivalent legal degree, and experience in drafting and negotiating Clinical Trial Agreements in a global setting.

What kind of experience is essential for negotiating contracts?

Experience with clinical study budgets and an understanding of contracting negotiation principles, practices, processes, and activities is essential for negotiating contracts.

How does this role collaborate with other departments?

This role partners with Legal, Finance, pCRO, and other divisions to manage escalations in budgeting and contracting, identify areas of improvement, and ensure alignment with compensation requirements.

Is prior experience in a matrix-based organization important for this role?

Yes, demonstrated success in working within a highly matrix-based organization is an important qualification for this position.

What type of work environment does Pfizer offer for this role?

Pfizer offers a remote, field-based work environment, promoting a flexible workplace culture that aims for work-life harmony.

How does Pfizer approach diversity and inclusion?

Pfizer is committed to building a diverse and inclusive workforce, celebrating all forms of diversity to better represent the patients and communities it serves.

What does Pfizer mean by being a disability inclusive employer?

Pfizer's commitment as a disability inclusive employer means ensuring equal employment opportunities for all candidates and making reasonable adjustments to support their application and future career.

Pharmaceutical Manufacturing

Science & Healthcare
Industry
10,001+
Employees
1849
Founded Year

Mission & Purpose

Pfizer is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative healthcare solutions. They are committed to improving the health and well-being of people around the world. Pfizer's mission is to be a leading force in the fight against diseases and to provide access to safe, effective, and affordable medicines. Their purpose is to make a positive impact on society by advancing medical science, developing breakthrough therapies, and collaborating with healthcare professionals and partners to address unmet medical needs. With a focus on research, development, and the production of pharmaceutical products, Pfizer plays a vital role in shaping the future of healthcare and improving patient outcomes.