Senior Clinical Trial Manager (Oncology)
Company: Bold Steps Behavioral Health
- Location: Cleveland, United States
- Seniority: Senior
- Employment type: Full-time
- Posted: 9 days ago
- Offer language: English
Job description
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.
