Investigator Contracts Lead 1

Pfizer; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks an Investigator Contracts Lead to oversee contract negotiations and budget management for clinical trials. The role involves collaboration with various departments to ensure compliance and efficiency in the contracting process, making it crucial for the success of clinical studies. Candidates should have significant experience in clinical development operations and strong negotiation skills.

Benefits

Paid parental leave

Access to Health & Wellness apps

Career Growth Experiences program

Recognition & rewards program

Paid volunteer days

Life Insurance Benefits

Pfizer Learning Academy access to top content providers

Access to flu vaccines & skin checks

Options to purchase additional leave

Salary packaging & novated lease options

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 global clinical study agreements.
• Manage site budgeting processes and contractual terms.
• Lead relationships with investigational sites and Site Management Organizations.

Skills

Negotiation

Communication

Risk Management

Leadership

Compliance

Education

Bachelor’s degree

US Juris Doctorate or equivalent legal degree

Job description

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

Indicate the primary responsibilities critical to the job.

• 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

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

• Paid parental leave

• Access to Health & Wellness apps

• Career Growth Experiences program

• Recognition & rewards program

• Paid volunteer days

• Life Insurance Benefits

• Pfizer Learning Academy access to top content providers

• Access to flu vaccines & skin checks

• Options to purchase additional leave

• Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.

Global Procurement
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