Clinical Trial Manager II
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Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol / GCP / regulatory compliance and data integrity.
Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.
May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs / CeMs) is aware of the contractual obligations and parameters.
Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
Participates and presents in key meetings such as Kick Off Meeting.
Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
This may include accompanying CRA team members to sites for observation or conflict resolution.
Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
Reviews and provides feedback on other functional plans (eg. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
Ensures access and audit trail reviews are conducted as required.
Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS / IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits / calls, duration, and frequency) according to plan.
Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP / SMP, and risk plans.
Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol / GCP compliance, trial conduct, patient safety or data integrity.
Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and / or sponsor specifications, including delivery deadlines.
Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.
Provides solutions for obstacles in protocol execution and site management.
Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).
Supports Inspection Readiness for clinical trial management scope.
Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
Develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines.
Provides feedback to line managers on staff performance including strengths as well as areas for development.
May be assigned to larger, more complex trials.