Clinical Trial Manager

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Requirements:

• BA/BS required
• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
• 5+ years of applicable clinical trial experience (2-5 years of vendor and CRO management) required
• Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
• Must be willing to travel both domestic and international
• Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
• Experience working on project teams is required
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., data management, biostatistics, regulatory, pharmacovigilance, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results.

Responsibilities:

• Supports the clinical team in the overall management of studies, including planning, execution and closeout of one or more clinical trials in accordance with clinical development plans/strategy and timelines
• Assist with the evaluation, selection, and oversight of CROs, external vendors and consultants to ensure successful clinical trial implementation and execution
• Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, and trial status updates
• Review and approve study-related operational plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
• Ensure audit-ready condition of clinical trial documentation including the trial master file
• Review and provide input on clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner
• Ensures risks are proactively identified, managed, and mitigation strategies implemented
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
• Assist with planning and conduct of investigators’ meetings
• Assist with monitoring progress of clinical study activities and report on the progress of assigned clinical trials including budget and timelines
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
• Participate in the preparation and review of SOPs
• Attend and provide support in meeting scheduling and distribution of meeting agendas/minutes
• Perform any other business need identified by their direct line Manager.