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Investigator Contracts Lead - Manager (m/f/d)

JR Germany

Oldenburg

Remote

EUR 70.000 - 100.000

Vollzeit

Vor 9 Tagen

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Zusammenfassung

A leading company is seeking an Investigator Contracts Lead to manage contract negotiations and site budget processes for clinical studies. This remote role involves strong communication and leadership skills, requiring a bachelor's degree and significant experience in clinical development. Join in shaping innovative solutions that guide trial timelines while balancing risks effectively.

Qualifikationen

  • 5+ years of experience in clinical development operations or outsourcing.
  • Experience with clinical study budgets and contract negotiations.

Aufgaben

  • Negotiate and execute global clinical study agreements.
  • Oversee global site budget process and manage site contracting activities.
  • Build and maintain relationships with investigative sites.

Kenntnisse

Strong communication
Risk management
Leadership

Ausbildung

Bachelor's degree

Jobbeschreibung

Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations throughout contract execution with assigned clinical investigator sites, including initial agreements and amendments, as well as oversight of other contracting professionals on assigned studies. This role also involves managing the Per-Subject Cost (PSC) process, handling escalation and resolution of budget and non-legal term issues, and collaborating with other teams to plan site contracting timelines for study start-up.

The key responsibilities include:

  1. Exercising good judgment in balancing Pfizer's risks in budget and contractual decisions against clinical trial timelines.
  2. Developing, negotiating, tracking, and executing global clinical study agreements following GPD processes.
  3. Overseeing the global site budget process.
  4. Negotiating costs and contractual terms directly with investigators and institutions.
  5. Building and maintaining relationships with investigative sites and Site Management Organizations.
  6. Leading study-level site contracting activities and serving as the primary contact for site issues.
  7. Partnering with Legal and other divisions to manage escalations and improve processes.

The role requires:

  • 5+ years of experience in clinical development operations or outsourcing, with a bachelor's degree.
  • Experience with clinical study budgets and contract negotiations.
  • Strong communication, risk management, and leadership skills.

Preferred qualifications include:

  • 2+ years of experience in clinical trial outsourcing and a legal degree such as a US Juris Doctorate.
  • Experience drafting and negotiating Clinical Trial Agreements in a global setting.

Work location: Remote

Pfizer's values are Courage, Excellence, Equity, and Joy, guiding our corporate culture and initiatives in diversity, inclusion, and sustainability.

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