Sr. Clinical Trial Leader (united States)
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 Clinical Trial Leader (CTL) to join our A-team (hybrid*/remote). As a 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.
• *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
• Coordinates and provides support for trial related (site) audits & inspections
• Contributes to corrective and preventive action plans where needed and ensures their timely implementation and closure
• Ensures project consistency within and across projects by following Allucent / relevant SOPs.
• Assists and supports in the preparation of various training material used by Allucent (including SOPs training, as well as specific trial related).
• Assists in the preparation and conduct of Kick-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested.
• Prepares Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable.
• Supports PM in the management of trial vendors as required.
• Project contract awareness and oversight; i.e.:
+ Forecast and report on the site management units throughout project life cycle
+ Identify changes in scope and liaise with the Project Manager
• Manages client expectations related to Clinical deliverables in accordance with contracted services and Allucent QMS.
• Provides input into proposals when required.
• Actively participates in the preparation, attendance and presentation of bid defenses or any other presentations to potential clients
• Complete routine administrative tasks in a timely manner (e.g. timesheets, travel expense claims, training)
• Other responsibilities as required.
Apply Now
Apply Now
We are looking for a Clinical Trial Leader (CTL) to join our A-team (hybrid*/remote). As a 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.
• *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
• Coordinates and provides support for trial related (site) audits & inspections
• Contributes to corrective and preventive action plans where needed and ensures their timely implementation and closure
• Ensures project consistency within and across projects by following Allucent / relevant SOPs.
• Assists and supports in the preparation of various training material used by Allucent (including SOPs training, as well as specific trial related).
• Assists in the preparation and conduct of Kick-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested.
• Prepares Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable.
• Supports PM in the management of trial vendors as required.
• Project contract awareness and oversight; i.e.:
+ Forecast and report on the site management units throughout project life cycle
+ Identify changes in scope and liaise with the Project Manager
• Manages client expectations related to Clinical deliverables in accordance with contracted services and Allucent QMS.
• Provides input into proposals when required.
• Actively participates in the preparation, attendance and presentation of bid defenses or any other presentations to potential clients
• Complete routine administrative tasks in a timely manner (e.g. timesheets, travel expense claims, training)
• Other responsibilities as required.
Apply Now
Apply Now