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

ZipRecruiter

Potsdam

Remote

EUR 70.000 - 90.000

Vollzeit

Vor 2 Tagen
Sei unter den ersten Bewerbenden

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Zusammenfassung

A leading company is seeking an Investigator Contracts Lead responsible for contract and budget negotiations with clinical investigator sites. The role includes managing agreements and resolving issues, requiring significant experience in clinical operations. This position supports values of courage, equity, and employee well-being while offering a remote working environment.

Qualifikationen

  • 5+ years of experience in clinical development operations.
  • Experience with clinical study budgets and contract negotiations.
  • Knowledge of business, compliance, finance, and drug development.

Aufgaben

  • Manage contract and budget negotiations with clinical investigator sites.
  • Oversee global site budget process and contractual term negotiations.
  • Collaborate with various teams to ensure alignment and process improvements.

Kenntnisse

Excellent communication skills
Risk mitigation
Leadership by influence

Ausbildung

Bachelor's degree
JD or equivalent legal degree

Jobbeschreibung

Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations from contract initiation to execution with assigned clinical investigator sites. This includes managing initial agreements, amendments, and overseeing other contracting professionals involved in the studies. The role also entails managing the Per-Subject Cost (PSC) process, handling escalation and resolution of budget and non-legal issues, and collaborating with various teams to plan site contracting timelines during startup.

The key responsibilities include:

  1. exercising good judgment in balancing Pfizer's risks with trial timelines,
  2. following GPD processes for developing, negotiating, tracking, and executing global clinical study agreements,
  3. developing and overseeing the global site budget process,
  4. negotiating costs and contractual terms directly with investigators and institutions,
  5. building relationships with investigational sites and Site Management Organizations,
  6. leading study-level site contracting activities and acting as the primary contact for site issues,
  7. partnering with Legal and other divisions to manage escalations,
  8. collaborating on process improvements in site contracting,
  9. applying principles of business discipline, and
  10. working with invoicing teams to ensure alignment with contracting and compensation requirements.

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,
  • knowledge of business, compliance, finance, legal, and drug development,
  • excellent communication skills,
  • ability to mitigate risks to timelines,
  • leadership by influence, and
  • success in a matrix organization.

Preferred qualifications include:

  • 2+ years of experience in clinical operations or outsourcing with a JD or equivalent legal degree,
  • experience drafting and negotiating Clinical Trial Agreements in a global setting.

The position is remote, supporting Pfizer's values of Courage, Excellence, Equity, and Joy, with a focus on diversity, inclusion, and employee well-being.

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