Sr. Clinical Trial Leader (united States)

Remote, USA • Full-time • Posted 2026-05-04

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.

*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.:
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.