Clinical Trial Manager - Contractor

The Clinical Trial Manager will provide clinical study support to the Clinical Program Manager/Study Management Team Lead for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. The position will report to a Clinical Operations Manager and will be responsible for managing clinical trials from start to finish, including vendor management, site oversight, data management, and regulatory compliance.

Requirements

• Day-to-day management of assigned operational aspects of low to medium complex clinical trials
• Obtains and reviews all required essential documents necessary for study/site initiation
• Maintains/files accurate and timely sponsor/site correspondence and communication
• Performs tasks in accordance with ICH GCP, regulations, the protocol, and company SOPs/Policies
• Supports the development and review of clinical study plans, presentations or study-related documents
• Assists with set-up of central labs and study vendors as required
• Works closely with data management lead to perform data cleaning activities with cross-functional team
• May lead and coordinate protocol deviation review and documentation
• Manage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• May perform accompanied site visits with CRO Site Monitors
• Reviews monitoring trip reports and track resolution of all action items
• Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
• Assists with providing oversight of CROs and vendors
• Coordinates with CRO and SMTL in clinical site oversight, data entry timeliness, assists with resolving site issues
• Assists with set-up and review of clinical TMF
• Organizes and manages internal team meetings, investigator meetings, and other trial­ specific meetings, as requested
• Contributes to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient facing materials, etc.
• Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable
• Recommend and implement innovative ideas to increase efficiency and quality of program management activities
• Contributes to process and departmental and cross-functional improvement activities