Senior Clinical Trial Project Manager, Beat AML
How many people can answer the question, "What do you do for a living?" with the
answer, "I help find cures for cancer." At Blood Cancer United, employees take our
mission seriously. Whether you work in one of our regions, are an accountant at the
national office or a specialist in our Information Resource Center, you work each day
on making our bold goal a reality: to enable patients with blood cancer to
gain more than one million years of life by 2040. Join us and give new
meaning to the word, "job."
Overview: The Senior Clinical Trial Project Manager (Senior PM) provides strategic leadership and operational oversight for a portfolio of clinical trials, ensuring the successful execution of complex, multi-site studies from planning through closeout. This role serves as a senior liaison between Blood Cancer United, pharmaceutical partners, academic partners, CROs, and internal leadership, with accountability for project quality, financial performance, timelines, and risk management across multiple studies. The Senior PM ensures consistency in execution, adherence to regulatory standards, and continuous improvement in clinical trial delivery. This position bridges strategic planning and hands-on execution, providing both high-level guidance and targeted intervention when needed.
Key Responsibilities:
Strategic Trial Oversight and Leadership
- Provide senior-level oversight for a portfolio of clinical trials, ensuring alignment with organizational goals, sponsor expectations, and scientific objectives.
- Serve as the primary escalation point for complex operational, financial, and regulatory issues across assigned studies.
- Partner with leadership to define trial strategies, operational models, and long-term resource planning.
- Support business development efforts by leading or contributing to bid strategy, feasibility assessments, and sponsor defense meetings for complex trials.
- Guide and approve trial scope, budgets, and timelines prior to contract finalization.
Trial Planning, Execution, and Risk Management
- Provide strategic oversight and development and approvals of project plans, timelines, and vendor strategies.
- Review and provide guidance on trial protocols and key study documents to ensure operational feasibility.
- Ensure effective collaboration between Beat AML team, CROs, investigators, and site teams.
- Proactively identify cross-study risks, trends, and systemic issues, implementing mitigation strategies as needed.
- Support CTMs in resolving complex study challenges and navigating out-of-scope work or contractual changes.
- Facilitate decision-making at the portfolio level to optimize study execution and resource utilization.
- Ability and willingness to help the team when needed to meet deadlines, pulling reports, analyzing clinical data, cleaning data, reviewing TLFs, CSRs, abstracts, etc.
Stakeholder and Executive Communication
- Maintain senior-level relationships with pharmaceutical partners and key external stakeholders.
- Schedule, prepare and assist in advisory committee meetings including the Data Safety Monitoring Committee (DSMC) and Joint Development Committee (JDC) Meetings.
- Prepare and present executive-level updates to Blood Cancer United leadership, including portfolio performance, financials, and risk assessments.
- Represent clinical operations in cross-functional and leadership forums.
Quality, Compliance, and Process Improvement
- Ensure all assigned trials maintain a continuous state of audit readiness.
- Provide oversight to ensure compliance with ICH/GCP, FDA, and IRB/IEC requirements.
- Review and trend key metrics across studies to identify improvement opportunities.
- Lead or contribute to the development and enhancement of clinical operations processes, tools, templates, and training materials.
Qualifications:
Education and Experience
- Bachelor’s degree in life sciences, nursing, pharmacy, medical sciences, or a related field required