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Investigator Contracts Lead 1 (Clinical Development Ops)

5+ years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Investigator Contracts Lead

Department: Global Procurement


Job Summary

The Investigator Contracts Lead (ICL) is responsible for direct, site-facing contract and budget negotiations, including initial agreements, amendments, and oversight of contracting professionals for assigned clinical investigator sites. The role involves managing Per-Subject Cost (PSC) processes, escalating and resolving budget and non-legal term issues, and collaborating with cross-functional teams to plan site contracting timelines during clinical study start-up.


Job Responsibilities

Contract & Budget Negotiations

  • Develop, negotiate, track, and execute global clinical study agreements with investigators and institutions.
  • Manage site budgets, negotiate costs, and adapt contractual terms in accordance with Legal division-approved parameters.
  • Oversee study-level contracting activities and timelines for assigned studies.

Stakeholder Collaboration

  • Lead and foster relationships with investigational sites and Site Management Organizations.
  • Partner with Legal, Finance, and other divisions to address and resolve escalations related to site budgeting and contracting.
  • Collaborate with invoicing specialists or service providers to ensure alignment with site contracting and compensation needs.

Process Improvement

  • Identify and implement improvements in the site contracting process in collaboration with pCRO and cross-functional teams.
  • Contribute to the design, development, and execution of major business initiatives and special projects.

Risk Management

  • Plan and mitigate risks to site contracting timelines.
  • Exercise sound judgment in balancing contractual decisions with clinical trial timelines and Pfizer’s risk exposure.

Compliance

  • Ensure adherence to organizational processes, compliance requirements, and contractual obligations.

Qualifications and Skills

Basic Qualifications

  • Bachelor’s degree with 5+ years of experience in clinical development operations or clinical trial outsourcing.
  • Proficiency in clinical study budgets and contracting negotiation principles.
  • Strong communication and presentation skills.
  • Demonstrated ability to work in a matrix-based organization and influence without positional authority.

Preferred Qualifications

  • 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.

Core Competencies

  • Balance of general business, compliance, finance, legal, and drug development expertise.
  • Strategic planning skills and ability to identify and mitigate risks effectively.

About Pfizer

Purpose

At Pfizer, we are guided by our values of courage, joy, equity, and excellence. Our mission is to create breakthroughs that transform lives.

Digital Transformation

Pfizer is leading innovation through a digital transformation strategy that integrates data, modeling, and automation to accelerate drug discovery and development while improving patient outcomes.

Flexibility

We foster a flexible, trusting workplace culture that empowers employees to achieve work-life harmony while delivering their best work.

Diversity and Inclusion

Pfizer celebrates diversity in all forms and is committed to fostering an inclusive environment. We believe this is critical to building a successful business and serving diverse communities.

Disability Confident

We proudly support employees with disabilities by providing reasonable accommodations to ensure their success.


Work Location Assignment

Remote - Field Based


Equal Employment Opportunity

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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