Sr. Clinical Trial Leader (United States or Canada)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Sr. Clinical Trial Leader (Sr. CTL) to join our A-team (hybrid*/remote). As a Sr. CTL at Allucent, you are responsible for providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality. The CTL serves as a proactive member of the core project team, liaising closely with the Project Manager (PM) and other department leaders if /when necessary on all trial-related issues and service delivery. The CTL will perform tasks with minimal supervision whilst assisting, mentoring, and supporting the CRA teams. The CTL may support the management team with training, process improvements, co-monitoring visits, mentoring of staff and / or any other special assignments within Global Clinical Operations.

In this role your key tasks will include:

• Coordinating and managing CRA activities across all geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (timeline, budget, quality, productivity) are met, including: Managing the trial start up and site activation in collaboration with PM, Global Regulatory Lead and, if applicable, Global Site Activation Manager (GSAM).
• Oversight of critical documentation collection, maintenance and filing.
• Develop the Monitoring Plan and site monitoring templates and tools as well as providing input into Trial plans & tools.
• Review trial-specific documents upon request as well as develops or reviews subject-facing materials. (if necessary)
• Customizes the annotated Site Visit Reports according to trial specific requirements.
• Selection of investigators and sites; SEV report review and approval.
• Site initiation management; SIV report review and approval
• Monitoring Visit Report (MVR) review, management, resolution and escalation.
• Where applicable, works with PM and / or patient recruitment manager to support the project recruitment timelines and (site) recruitment plan as well guiding the CRA team
• Manages successful trial close-out, identifies critical activities to make timely and efficient close-out.
• Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM, Line Manager, and GCO management .
• Provides information and input about planned activities and status to PM and attends Project Review Meetings if/when needed.
• Conducts project co-monitoring (if required) & if needed temporarily conducts site management / monitoring in case of immediate need and lack of resources.
• Coaches/mentors CRA team including providing performance feedback as appropriate, assisting in developing and delivering project-specific training and providing input related to Project Specific Training Matrix.
• Prepares and chairs CRA calls and actively participates in internal trial team calls and client calls.
• Oversees / attends CRA handovers as appropriate.
• Serves as a site contact for protocol clarifications and subject enrolment if CRA unavailable.
• Monitors and manages trial materials supplies ensuring Investigational Product and other trial supplies are shipped to sites.
• Reviews data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff.
• Oversees the process of protocol deviation and Trial non-compliance documentation, tracking and escalation.
• Participates in the development of trial newsletters communication.
• Requests appropriate Clinical Operations staffing, workload and resources and reports trial deliverables and resource needs.
• Assists, where appropriate, the PM in discussions with clients on trial documentation issues or technical related documentation concerns that may arise.
• Reviews trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on regular basis, ensures systems reports are up to date and reports generated are current and correct.
• Oversees eTMF status.
• Reviews trial reports and analyzes trends to recognize risks, provides input into mitigation plans and implements mitigations belonging to clinical activities
• Contributes to optimization of trial processes to increase efficiency
• Coordin