Investigator Contracts Lead, Sr. Manager - Poland

Pfizer; United States; Remote; USD 100,000 - 140,000; Full time

Job summary

Pfizer is seeking an Investigator Contracts Lead to manage contract negotiations and oversee budgeting for clinical trial sites. This remote role requires extensive experience in clinical development operations, with a focus on collaboration and problem-solving. Join a patient-centric company dedicated to transforming lives through innovative drug solutions.

Qualifications

• 7+ years of experience in clinical development or clinical trial outsourcing.
• Significant experience with clinical study budgets and negotiation.
• Demonstrated success in a matrix-based organization.

Responsibilities

• Lead site contracting negotiations and manage budget escalations.
• Develop and negotiate clinical study agreements with institutions.
• Collaborate with legal and financial divisions to improve site contracting.

Skills

Negotiation

Contract Management

Budgeting

Communication

Problem Solving

Education

Bachelor’s degree or equivalent

Master’s degree (preferred)

Juris Doctorate (preferred)

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 this 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.

QUALIFICATIONS / SKILLS

Basic Qualifications:

• 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.

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 of Clinical Trial Agreements with clinical trial sites ina global operation.

Work Location Assignment:Remote - Field Based

Purpose

Breakthroughs that change patients' lives... At Pfizer we are apatient 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.

Digital Transformation Strategy

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, modelling 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!

Equal Employment Opportunity

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!

Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address [e-mail].

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