Clinical Development Operations Specialist, Contract Management
Il y a 2 mois
Job Summary
The Site Contracts Template Specialist, Clinical Development is responsible for identifying, prioritizing, and achieving and maintaining an appropriate inventory of site contract templates. This role requires revising global, country, and site-specific templates to align with changing external (legal, regulatory, financial) and internal requirements.
Key Responsibilities
- Serve as a divisional subject matter expert for all country and site template updates for Pfizer Research & Development and Pfizer Oncology Divisions.
- Maintain strong business awareness, evaluating current and possible future policies, practices (including governmental acts and policies), trends, technology, and information potentially affecting Investigative Site Contracting.
- Recommend changes to templates based on knowledge and experience.
- Collaborate with Pfizer Legal to ensure Investigative Site contracting templates are maintained and continuously improved.
- Manage the introduction of revised templates by gaining appropriate approvals and efficiently communicating changes to all stakeholders, including those outside the site contracting group.
- Update contract template guidance and repository to support contract template changes.
- Ensure training is delivered and documented to site contracting professionals around Investigative Site Contracting policies, templates, and standards.
- Negotiate or oversee the negotiation and execution of assigned contracts.
Requirements
- 7+ years of experience in clinical development operations or clinical trial outsourcing and a bachelor's degree or equivalent.
- Experience in working with limited supervision to achieve business goals.
- Experience with contracts and negotiation principles, practices, processes, and activities is essential.
- Balance of general business, compliance, finance, legal, and drug development or legal/compliance experience in a regulated industry is essential.
- Strong and precise communications and presentation skills are essential to success.
- Record of achievement and delivery against personal goals.
- 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
- 5+ years of experience in clinical development operations or clinical trial outsourcing with a master's degree.
- 2+ years of experience in clinical development operations or clinical trial outsourcing with a Juris Doctorate (or equivalent).
- Expertise in drafting and negotiating Clinical Trial Agreements with clinical trial sites in a global operation.
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Paris, Île-de-France Pfizer Temps pleinJob SummaryThe Site Contracts Template Specialist, Clinical Development is responsible for identifying, prioritizing, and achieving and maintaining an appropriate inventory of site contract templates. This role requires revising global, country, and site-specific templates to align with changing external and internal requirements.Key Responsibilities Serve...
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