Jobs · Analyst · Ohio

Senior Clinical Trial Manager (Oncology)

Bold Steps Behavioral Health · Cleveland, OH · 1 wk ago
On-siteAnalystFull-time
Role Overview Serve as a subject matter expert ensuring quality, compliance, and adherence to SOPs, GCP, and regulatory standards across clinical studies.Lead site selection, feasibility, and recruitment strategies to meet study targets, providing strategic recommendations and managing local teams.Act as the primary country-level contact, overseeing trial operations, vendor management, and study supplies.Ensure trial compliance by maintaining accurate data, documentation, and inspection readiness; identify and resolve quality and safety issues proactively.Support patient safety through review of adverse events, manage informed consent processes, and ensure regulatory approvals.Lead operational planning, monitor study progress, and implement corrective actions; oversee budget and financial reporting.Provide training, mentorship, and contribute to process improvements, inspection preparation, and system implementations.Manage complex trial activities independently, including startup, site management, and regulatory compliance. Qualifications & Skills BA/BS in health or science-related field with 3-5+ years of trial management experience, particularly in complex clinical trials and oncology.Strong knowledge of ICH-GCP, SOPs, local laws, and protocol procedures.Proficiency in relevant IT systems, excellent communication skills in English and the local language, and willingness to travel.

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