Clinical Trial Manager II

The Clinical Trial Manager II (CTMII) is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical operations deliverables of clinical trials. This includes but is not limited to training and study level oversight of clinical research associate (CRA) activities, identifying and managing quality issues related to site performance and monitoring, ensuring adherence to study plans, developing action plans to address concerns, as well as ensuring timelines are met and study is conducted according to budgets.

• Ensures all clinical monitoring activities are performed in accordance with the Sponsor’s contract.
• Ensures timely, quality deliverables in accordance with applicable standard operating procedures (SOPs), ICH/GCP guidelines, regulations, laws, and study-specific requirements.
• Identifies quality issues and trends in site performance through KPI reviews, project meetings, site communications, and audit findings. Summarizes findings and establishes action plans to bring corrective actions forward to study team and sponsor, as applicable.
• Maintains an in-depth knowledge of the protocol, therapeutic area and indication.
• Serves as primary sponsor contact for operational site-specific issues and clinical deliverables;
• Contributes to internal, sponsor, and investigator meetings.
• Manages risk assessment and execution of mitigation.
• Serves contact for sponsor and project team for all clinical operations matters and clinical deliverables.
• Provides training/mentoring and oversight the CRAs, Lead CRAs, and other clinical operations staff, as applicable, Including overseeing the transition of CRAs.
• Accountable for site management activities, including (but not limited to) maintaining site contact lists, coordinating site training, and monitoring site performance).
• Manages site screening and enrollment oversight.
• Tracks site visit report metrics to ensure quality, compliance, and timely completion.
• Assess protocol deviations and related action items regularly.
• Develop the Monitoring Plan and contribute to the development of other study plans, manuals, reference materials, logs, and applicable site worksheets/instructions.
• Prepares and conducts project-specific training for the CRAs.
• Conducts quality assessment visits with CRAs.
• Coordinates and leads CRA meetings.
• Performs co-monitoring visits with CRAs.
• Oversees the development, performance, quality, and completion of SQV, SIV, SMV, COV (including annotated reports, follow-up letters, and other monitoring tools).
• May participate in business development activities (client meetings, bid defense meetings, requests for proposals (RFPs,) and requests for information (RFIs)). May provide training and/or mentoring to junior CTMs.
• May contribute to the development of tools and/or process improvements within the department.
• Manages tracking, forecasting, and reconciliation of project budget, including reviewing billed hours, tracking of out-of-scope (OOS) and contributing to change orders (CO) by providing recommendations and estimates to assist with budget preparation, cost justification, and financial planning for assigned studies.
• Proactively identifies issues proactively and present solutions to project team.
• Supports the achievement of team revenue objectives by delivering of clinical trials within agreed timelines and budgets.
• Contributes to improving or adapting existing and new processes, methods, or techniques.
• Applies prior experience and expertise to proactively solve complex issues, identify solutions and analyze outcomes.

The Clinical Trial Manager II may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified…