Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Investigator Contracts Lead 2 (Clinical Development Ops)
Job Description
Job Summary
Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations through 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 through start-up. This role may also act as a single point of contact for studies with high priority or complex or unique contracting structures and strategies and is expected to be able to plan and solve for situations with minimum oversight.
Job Responsibilities
• Exercise independent judgement and decision making in areas of site contracting with moderate supervision.
• Effective management of contract and budget escalations from FSP / pCRO ICL with limited consultation.
• Make appropriate decisions, with limited oversight while balancing the risks for Pfizer in making budget and contractual choices against the impacts to Pfizer clinical trial timelines.
• Problem solving for site contracting issues of moderate complexity. This includes suggesting and implementing unique solutions, as needed, to achieve study goals
• 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 other ICL, pCRO and FSP negotiators in achieving study goals with moderate support from site contracting team leads. 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 advanced knowledge of the principles, concepts and theories in site contracting and budgets.
• 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 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.
Candidate Profile
• 7+ years of experience in clinical development operations or clinical trial outsourcing and a bachelor’s degree or equivalent.
• Significant 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.
• 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 of Clinical Trial Agreements with clinical trial sites in a global operation.
Additional Information
Experience : 2+ year's
Qualification : master’s degree
Location : India - Remote
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December 2024
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