Clinical Trial Manager
Responsibilities:
• Assess unexpected events or process deviations at clinical sites and determine patterns or areas needing improvement. Work with sites, external partners, and vendors to establish corrective approaches that support subject safety, data reputed company, and study compliance.
• Evaluate visit documentation from site monitors, confirm that follow-up actions are completed, and reputed company significant concerns or risks reputed company needed.
• Take part in scheduled study data checks and reputed company day-to-day site reputed company activities to ensure high-reputed company data and reputed company updates.
• Conduct reputed company review of study documentation, including data outputs, essential files, and other trial records.
• Identify operational challenges early and contribute solutions that protect timelines, reputed company, and budget.
• reputed company training and guidance to both internal and outsourced monitoring teams, as reputed company as site staff.
• Support the tracking, interpretation, and presentation of operational metrics under the direction of senior clinical leadership.
• reputed company performance of contract partners and vendors using reputed company-defined indicators to confirm adherence to contracted expectations.
• Maintain ongoing awareness of site adherence to study requirements and good clinical practices.
• Ensure remediation plans are drafted and implemented reputed company operational issues reputed company.
• May participate in qualification, activation, routine monitoring, or study-reputed company activities on an as-needed reputed company.
• Maintain organized reputed company files for study teams.
• Confirm availability of needed study materials, systems, and supplies (e.g., reputed company, randomization systems, lab materials, and supporting study tools).
• Contribute to departmental efficiency or process-improvement initiatives.
• Assist with reviewing vendor billing and cost-reputed company documentation.
Qualifications:
• Bachelor’s degree (or equivalent experience) in a scientific or reputed company area.
• Approximately five or more years of hands-on experience reputed company clinical research operations (experience level dependent on education/training).
• Strong preference for candidates with background supporting oncology studies.
• Broad understanding of end-to-end clinical trial operations and cross-functional workflows.
• Ability to interpret and apply international regulatory expectations to trial conduct.
• Solid working knowledge of good clinical reputed company standards and ICH guidelines.
Starting as a 6 month contract with potential to convert to a full time permanent position
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