Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

We are looking for an experienced Clinical Trial Leader / Senior Clinical Trial Leader

The Clinical Trial Leader (CTL) provides 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.

This is a full-time, direct hire opportunity for an experienced Trial Leader residing in the US, Canada or Mexico. Ideal candidates should have a combination of SCRA CTL/CTM or Regulatory/Auditing industry experience providing oversight to Oncology, Infectious Diseases and/or Vaccine (Covid specific) clinical trials.

Location: Hybrid OR Remote role (depending on candidate location) in US or Canada

This position will be hybrid for those living near one of our office locations, however, for those further in distance the role can be offered remotely. Strong English Communication (written and verbal) is required.

Travel: On rare occasions where travel is needed, may require 10% travel to attend bid defense meetings, company visits, possible audits, etc.

Preferred TA experience: Oncology, Infectious Diseases, Vaccines (Covid specific)

The CTL/ Sr. CTL will be responsible for the following tasks:

• Responsible for 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: • Manages 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.
• Provide input into Trial plans and tools (e.g., protocol, Project Plan, Data Management Plan, eCRF Guidelines, TMF Plan, TMF Index, Risk Log, Recruitment Plan & trackers, Site Activation Management Plan, Regulatory and Ethics Submission Plan (RESP), Clinical Trial Agreement & Budget Plan (CTABP), Investigation Product Release Authorisation Plan (IPRAP), Trial Non-Compliance Management Plan, Medical Monitoring Plan, Safety Management Plan, Centralized Monitoring Plan, etc.)
• For trials with separate unblinded monitoring and when assigned unblinded CTL role, develops or assists the PM in the development of CRO Blinding Plan, Unblinding Plan and all necessary tools and templates for the unblinded monitoring and site activities.
• Reviews trial-specific documents upon request (e.g., Protocol, Subject Information Leaflet/Informed Consent Forms, Laboratory Manual, Pharmacy Manual)
• Develops or reviews subject-facing materials such as: Letter for the GP, Subject ID card, instructions for the subjects (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 .
• Coordinates and manages CRA site assignments, site visit schedules and site management activities.
• 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).
• Coaches/mentors CRA team. Provides performance feedback on team members as appropriate • Assists in developing and delivering project-specific training and provides 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.
• May be assigned to temporarily conduct site management and monitoring in case of immediate need and lack of resources.
• Monitors and manages trial materials supplies. Ensures 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.