Clinical Trial Manager - Contractor

Responsibilities

• Day-to-day management of assigned operational aspects of low to medium complex clinical trials, including but not limited to vendor/laboratory management, oversight of clinical sites, etc.
• Obtains and reviews all required essential documents necessary for study/site initiation
• Maintains /files accurate and timely sponsor/site correspondence and communication
• Prepares and presents project progress reports
• Manages and tracks patient enrollment, site performance and monitoring metrics
• Supports the development and review of clinical study plans, presentations or study-related documents
• Supports the development and design of CRFs, including participating in the EDC and I X RS specification process and UAT on related systems
• Aids in the set-up of central labs and study vendors as required, including liaising with Clinical Program Manager and CRO to ensure site training and timely initiation of clinical study sites
• Performs in-house review of clinical data listings for completeness and accuracy and escalates issues to the Clinical Program Manager, as needed
• Works closely with data management lead to perform data cleaning activities with cross-functional team
• May lead and coordinate protocol deviation review and documentation
• Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• Performs accompanied site visits with CRO Site Monitors to ensure correct study procedures according to SOPs and protocol procedures, review of routine regulatory documents/files in compliance with protocol, regulatory requirements, site and CRO SOPs, and study plans, as required
• Reviews monitoring trip reports and track resolution of all action items
• Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
• Aids in the coordination of clinical site oversight, data entry timeliness, and assistance with resolving site issues
• Aids in the set-up and review of clinical TMF
• Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as requested
• Contributes to the 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
• Recommends and implements innovative ideas to increase efficiency and quality of program management activities
• Contributes to process and departmental and cross-functional improvement activities

Qualifications

• Bachelor’s degree, preferably in a scientific field
• 5+ years of related industry experience in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience, preferably in oncology
• Demonstrates core understanding of clinical trial related terminology and activities
• Thorough understanding of ICH GCP guidelines and Code of Federation Regulations
• Understanding of clinical trial processes from study start-up through study closure
• Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
• Excellent planning and organization skills
• Self-motivated, assertive, and able to function independently and as part of a team
• Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
• Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.)
• Ability and willingness to travel 10-20% (domestic and international)