Investigator Contract Lead 1
Secteur : Industrie du médicament humain Famille de fonction : Services généraux
Description du poste et des missions
JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
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.
Profil souhaité
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
Compétences requises
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial 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.
