Investigator Contracts Lead, Manager

Pfizer; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company seeks an Investigator Contracts Lead responsible for managing contract negotiations and budget for clinical trial sites. The role includes overseeing budgeting processes and ensuring timely execution of agreements. Candidates should have substantial experience in clinical operations and possess strong negotiation skills, preferably with a legal background. This position embraces Pfizer's values of courage and equity, contributing to life-changing breakthroughs.

Qualifications

• 5+ years of experience in clinical development operations or clinical trial outsourcing.
• Experience with clinical study budgets and contracting negotiation principles.
• Ability to lead by influence in a matrix-based organization.

Responsibilities

• Negotiate and execute clinical study agreements with institutions.
• Manage budget and contracting timelines for clinical trials.
• Lead relationships with key investigational sites.

Skills

Clinical development operations

Contract negotiation

Project management

Communication skills

Risk identification

Education

Bachelor's degree

US Juris Doctorate or equivalent legal degree (preferred)

Job description

JOB SUMMARY

Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations thought contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also includes managing the Per-Subject Cost (PSC) process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or pCRO and collaborating with other lines to plan site contracting timelines though start-up.

JOB 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.

QUALIFICATIONS / SKILLS

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

Work Location Assignment:Remote - Field Based

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

School of Leaders

We, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

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