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Investigator Contract Lead Apply
locations: Italy - Rome, Europe - Remote
time type: Full time
posted on: Posted Yesterday
job requisition id: 4923904
JOB SUMMARY
The Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements, 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 through 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 contact 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 providers 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 the 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 contracting 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 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.
One bold way we are achieving our purpose is through our company-wide digital transformation strategy. We are leading the way in adopting new data, modeling, and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
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!
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.
Disability Inclusion:
Our mission is unleashing the power of all our people, and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
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