Clinical Trial Leader (Europe)

Allucent

Multiple Locations

Description

We are looking for a Clinical Trial Leader (CTL) to join our A-team (hybrid*/remote). As a Clinical Trial Leader 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 will perform tasks with minimal supervision whilst assisting, mentoring, and supporting the CRA teams.

In this role your key tasks will include:

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)
Customises 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.
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.
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.
Serves as a site contact for protocol clarifications and subject enrolment if CRA unavailable.
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.
Requests appropriate Clinical Operations staffing, workload and resources and reports trial deliverables and resource needs.
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.
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.
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, and identify changes in scope and liaise with the Project Manager.

Requirements

To be successful you will possess:

A degree in life sciences or nursing qualification.
A minimum of 5 years clinical research experience with at least 2+ years as Lead CRA.
In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trials.
Strong therapeutic background.
Strong written and verbal communication skills including good command of English language.
Professional and strong client focused.
Ability to work in a fast-paced challenging environment of a growing company.
Administrative excellence with attention to detail and accuracy.
Leadership and mentoring skills.
Excellent team player with team building skills.
Strong organizational skills to be able to manage a full workload across multiple projects.
Ability to mentor and train other CRAs in a positive and effective manner.
Demonstrates flexibility for creating solutions and process improvement.
Analytical, financial and problem resolution skills.
Proficiency with various computer applications such as Word, Excel, and PowerPoint, CTMS, eTMF required.
Ability to successfully manage people/project issues.
Mature management skills demonstrated by calm and thorough review of situations. Seeks to understand all contributing factors.
Proposes, implements, and evaluates appropriate, creative resolutions.
Demonstrates the ability to define and meet project requirements.