Senior Clinical Trial Manager

Responsibilities

• Day-to-day management of assigned operational aspects of 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.
• Lead the development and review of clinical study plans, presentations or study-related documents.
• Supports in the development and design of CRFs, including participating in the EDC and I X RS 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.
• 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.
• 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.
• Coordinates with CRO and SMTL in clinical site oversight, data entry timeliness, assists with resolving site issues.
• Aids in the set-up and review of clinical TMF.
• Mentors junior team members.
• 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.
• 6 + years of related industry experience in the pharmaceutical industry or equivalent, plus 3 + 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 Federal 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).
• Demonstrates problem solving and decision-making skills.
• 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).