Clinical Trial Manager - Contractor

Summary

The Clinical Trial Manager - Contractor (CTM) will provide clinical study support to the Clinical Program Manager/Study Management Team Lead (SMTL) for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications.

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
• 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
• Support in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT on related systems
• Assists with 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 escalate 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
• 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 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)
• 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

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)

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