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Investigator Contracts Lead 1 (Clinical Development Ops)

5+ years
Not Disclosed
10 Dec. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills:

Job Title: Investigator Contracts Lead
Department: Global Procurement
Work Location Assignment: Remote - Field Based


Job Summary

The Investigator Contracts Lead (ICL) is responsible for managing site-facing contract and budget negotiations from initiation through execution, including initial agreements and amendments, for clinical investigator sites. This role includes oversight of other contracting professionals on assigned studies, managing the Per-Subject Cost (PSC) process, and resolving budget and contractual issues. The ICL collaborates with various stakeholders to plan site contracting timelines, ensuring adherence to Pfizer's clinical trial objectives.


Key Responsibilities

Contracting and Budget Management:

  • Develop, negotiate, track, and execute global clinical study agreements with investigators and institutions.
  • Directly negotiate costs and contractual terms with clinical trial sites, including amendments within Legal-approved parameters.
  • Oversee and standardize the global site budget process.
  • Manage escalation of budget and non-legal contractual issues, collaborating with Legal, Finance, and other divisions.

Leadership and Collaboration:

  • Act as the primary study-level contact for site contracting issues and timelines.
  • Lead study-level contracting activities and oversee the work of other ICLs.
  • Foster relationships with key investigational sites and Site Management Organizations.
  • Partner with Legal and stakeholders to implement improvements in site contracting processes.

Process and Compliance:

  • Exercise judgment in balancing risks and impacts on clinical trial timelines.
  • Ensure alignment of contracting and compensation requirements with invoicing processes.
  • Contribute to design and implementation of major business initiatives or special projects.

Qualifications / Skills

Basic Qualifications:

  • Bachelor’s degree with 5+ years of experience in clinical development operations or clinical trial outsourcing.
  • Strong expertise in clinical study budgets, contract negotiation principles, and processes.
  • Demonstrated ability to lead through influence within a matrix organization.
  • Proficient communication and presentation skills.
  • Ability to plan and mitigate risks affecting site contracting timelines.

Preferred Qualifications:

  • US Juris Doctorate or equivalent legal degree with 2+ years of experience in clinical development operations or trial outsourcing.
  • Hands-on experience drafting and negotiating Clinical Trial Agreements globally.

About Pfizer

Purpose:
At Pfizer, we are driven by our mission to create breakthroughs that transform patients' lives. Guided by our core values of courage, joy, equity, and excellence, we continuously strive for innovation and excellence in everything we do.

Digital Transformation:
Pfizer is at the forefront of digital transformation, leveraging data, modeling, and automation to enhance drug discovery and development.

Flexibility:
We foster a workplace culture that supports work-life harmony and encourages employees to perform at their best.

Equal Employment Opportunity:
Pfizer is committed to diversity and inclusivity, ensuring a culture that celebrates and empowers individuals in all forms.

Disability Confident:
As a Disability Confident Employer, Pfizer provides reasonable accommodations to support applicants and employees with unique abilities.


Global Procurement
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