Senior Project Manager - Oncology

New

Remote, United StatesFull-TimeSenior

Salary$147,300 — $220,900 USD

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Job Details

Experience: Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience
Required Skills: Project ManagementRisk Management

Bachelor’s degree in a science or health-related field (advanced degree preferred).
Minimum of 7 years of clinical research experience.
Minimum of 4 years of direct project management experience.
Proven experience managing complex and global clinical trials.
In-depth experience in pharmaceutical and/or device research.
Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint) and Microsoft Project.
Familiarity with eTMF, EDC, and CTMS software.
Knowledge of ICH-GCP guidelines and standard operating procedures.
Strong communication, negotiation, and interpersonal skills.
Ability to travel domestically and internationally as required.
Experience with oncology and cell and/or gene therapy (preferred).

Serve as primary point-of-contact and primary escalation point to the client.
Coordinate and oversee all functional services including external vendors to the established timeline and budget.
Manage the study budget, ensuring project remains within scope and handling out of scope activities.
Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation.
Ensure quality management for assigned projects, including eTMF inspection readiness and corrective action plans.
Maintain integrated collaboration with clinical operations and functional teams.
Prepare project status updates, report on key performance indicators, and lead client and internal meetings.
Conduct formal presentations for diverse audiences including investigative staff and clients.

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