Manager, Medical Operations

The role leads study budget management activities, including Fair Market Value (FMV) assessments and budget negotiations, while supporting project planning and execution, stakeholder and vendor management, performance tracking, and the development and maintenance of project timelines, priorities, and operational metrics to support successful study execution and organizational objectives. Supports the operational management of the US Oncology Investigator-Initiated Research (IIR) program by partnering with cross-functional stakeholders across US Medical Affairs, Clinical Development, and Alliance organizations.

Job Summary (Primary function):
This position is responsible for the operational oversight and coordination of multiple US Medical Affairs (USMA) projects and research initiatives, including Investigator-Initiated Research (IIR) studies. The role leads study budget management activities, including Fair Market Value (FMV) assessments and budget negotiations, while supporting project planning and execution, stakeholder and vendor management, performance tracking, and the development and maintenance of project timelines, priorities, and operational metrics to support successful study execution and organizational objectives.

Essential Functions of the Job: Study Budget Management
Investigator Initiated Research (IIR) Budget Management:

• Serve as the primary contact for completing IIR study budget Fair Market Value (FMV) assessment
• Review, evaluate, and negotiate IIR study budgets and line-item requests with study sites to ensure alignment with FMV guidelines and organizational standards.
• Partner with IIR Project Managers to review budget requests, resolve outstanding questions, and provide timely feedback to study sites.
• Maintain internal budget benchmarking data and recommend updates based on market trends, historical experience, and current rates.
• Prepare and distribute quarterly reports and summaries of finalized IIR study budgets.

Company Sponsored Study Budget Management:

• Develop site budget templates and negotiation parameters, or review and approve CRO-developed budget templates to ensure consistency and alignment with organizational standards.
• Review and provide guidance on site budget escalation requests submitted by CROs.

Additional Job Functions and Responsibilities

IIR Program Submission and Review:
Supports the operational management of the US Oncology Investigator-Initiated Research (IIR) program by partnering with cross-functional stakeholders across US Medical Affairs, Clinical Development, and Alliance organizations. Facilitates communication, coordinates meetings, and maintains documentation to ensure alignment and efficient execution of program activities.
Maintains IIR tracking tools and performance metrics to provide portfolio visibility and support risk management. Additionally, supports vendor oversight activities, delivers training on IIR systems and processes, and serves as a point of contact for user support and issue resolution.
Preclinical IIR Project Management:
Provide operational support for early-stage research initiatives by coordinating study startup, activation, execution, and closeout activities. Responsibilities include contract coordination, FMV budget assessments, drug supply oversight, and related financial processes in collaboration with investigators, study sites, Legal, and other internal stakeholders.
IIR and Research Project Management:
Support the management of Investigator-Initiated Research (IIR) and studies by partnering with cross-functional team members to facilitate concept and protocol reviews and coordinate study execution, maintenance, and closeout. Ensure study activities are completed within established timelines and budgets and in accordance with policies, SOPs, and work instructions.
Monitor study progress, milestones, and deliverables, proactively identifying, escalating, and helping mitigate risks that may affect timelines, budgets, quality, or study objectives. Develop and maintain project plans, priorities, budgets, and performance metrics, while coordinating activities across internal stakeholders, CROs, vendors, and study sites. Provide operational and vendor oversight to support timely, compliant, and high-quality study execution.
Qualifications (Minimal acceptable level of education, work experience, and competency):

• Bachelor s degree (B.A. or B.S.) required.
• Minimum of five years of relevant experience in pharmaceutical, biotechnology, clinical research, or related industry.
• Demonstrated experience in study budget evaluation, FMV assessment, and site budget negotiation.
• Demonstrated project management experience supporting clinical or Medical Affairs research.
• Advanced proficiency with Microsoft Office applications, project management tools, and document management systems.
• Demonstrated success in building productive relationships with diverse internal and external stakeholders through strong communication, collaboration, and interpersonal skills.
• Dependable self-starter with strong organizational skills and the ability to manage competing priorities and meet strict deadlines in a highly metrics-driven environment.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

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