Program Manager, Clinical Research Operations jobs in United States
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Columbia University Irving Medical Center · 3 weeks ago

Program Manager, Clinical Research Operations

Columbia University Irving Medical Center is seeking a Program Manager for Clinical Research Operations who will play a critical role in the Clinical Protocol & Data Management Office. This position involves providing leadership and oversight for clinical trials, ensuring compliance, financial responsibility, and collaboration among various stakeholders.

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H1B Sponsor Likelynote

Responsibilities

Serve as a role model and resource to team members, providing mentorship and guidance
Participate in CPDM leadership and other cancer center committees as assigned
Help streamline workflows and processes to enhance operational efficiency and consistency
Collaborate on the development and implementation of policies, procedures, and standard operating procedures (SOPs) to ensure compliance with institutional and regulatory requirements
Build effective relationships with internal and external stakeholders, including investigators, clinical departments, sponsors and finance partners
Communicate effectively across the organization, escalating unresolved operational or financial issues appropriately
Support recruitment and retention strategies
Work collaboratively with the Medical Director, investigators, and other CPDM leadership to promote compliant conduct of research
Serve as the primary liaison between CPDM leadership, CTO, and Finance managers to strengthen coordination on financial processes, study funding, and operational oversight
Identify gaps, inefficiencies, and risks in financial workflows, research billing processes, and budget governance, recommending and implementing improvements
Assist in the development, negotiation, interpretation, and monitoring of study budgets across all phases of the trial in partnership with the CTO CPDM DBT and leadership
Lead the creation and delivery of training for research staff on budgets, billing compliance, and financial components of trial management, including how financial elements align with operational workflows
Develop and institute CTMS financial management training with the CTO to ensure accurate and consistent documentation of budgets, accruals, milestones, and billing
Develop and manage a compliance oversight system for CTMS, ensuring data accuracy and alignment between operational and financial reporting
Support the pre-award, post-award, and close-out processes for all projects, serving as a resource
Identify, analyze, and address budget variances
Support initiatives related to participant recruitment and retention, evaluating the financial feasibility of proposed strategies
Provide oversight for multicenter trial activities, including sub-site budget review, invoicing, reimbursement tracking, and monitoring
Serve as a liaison with institutional partners including the CTO, Sponsored Projects Administration (SPA), IRBs, and Research Billing Compliance
Contribute to development and refinement of SOPs and guidance documents, including those related to financial workflows, CTMS documentation, and billing compliance
Lead special projects and additional assignments as requested by the Director of Clinical Research Operations
Perform other related duties and responsibilities as assigned/requested

Qualification

Oncology ResearchBudget ManagementFinancial OversightManagement ExperienceCTMS DocumentationMS Word ProficiencyMacPC FamiliarityCCRP/CCRC CertificationInterpersonal SkillsOrganizational Skills

Required

Bachelor's degree or equivalent in education and experience plus 4 years of related experience

Preferred

Minimum of 2 years Management experience
5 years of Oncology Research experience
Excellent interpersonal and organizational skills
Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms
CCRP/CCRC certification preferred but should be completed within 6 months

Company

Columbia University Irving Medical Center

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Columbia University Irving Medical Center is a clinical and educational enterprise that offers medical, dental, and nursing services. It is a sub-organization of Columbia University.

H1B Sponsorship

Columbia University Irving Medical Center has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (433)
2024 (353)
2023 (333)
2022 (370)
2021 (283)
2020 (221)

Funding

Current Stage
Late Stage

Leadership Team

D
Donna Lynne
Senior Vice President and COO
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