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 PRD 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 PRD or WSR Functional Line level – e.g., WSR Worldwide Safety, WSR Worldwide Regulatory Operations, PRD 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
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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