Senior Clinical Trial Leader

Summary

Join Allucent™ as a Clinical Trial Leader (CTL) and lead a team of Clinical Research Associates (CRAs) in the successful execution of clinical trials globally. You will manage all aspects of clinical trial activities, from start-up to close-out, ensuring adherence to timelines, budgets, and quality standards. Responsibilities include coordinating CRA activities, overseeing documentation, developing monitoring plans, and managing trial materials. The ideal candidate possesses a life sciences degree, 5+ years of clinical research experience (including CTL/CTM experience), and in-depth knowledge of ICH GCP. Strong communication, leadership, and organizational skills are essential. Allucent offers a comprehensive benefits package, flexible working hours, remote/hybrid work options, and professional development opportunities.

Requirements

• Be legally authorized to work in the specified Country where job is being advertised
• Have a degree in life sciences or nursing qualification
• Have a minimum of 5 years clinical research experience (including a combination of SCRA + CTL/CTM, PM or Regulatory/Auditing experience) with at least 1- 2 + years CTL/CTM experience (depending on selected level CTL / Sr. CTL)
• Have in-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trials
• Have a strong therapeutic background
• Possess experience and knowledge in the CRO industry that will support Allucent’s management of clinical trials Skills
• Have strong written and verbal communication skills including good command of English language
• Be professional and have strong client focus
• Have the ability to work in a fast-paced challenging environment of a growing company
• Have administrative excellence with attention to detail and accuracy
• Have leadership and mentoring skills with ability to mentor and train other CRAs in a positive and effective manner
• Be an excellent team player with team building skills
• Have strong organizational skills to be able to manage a full workload across multiple projects
• Demonstrate flexibility for creating solutions and process improvement
• Have analytical, financial and problem resolution skills
• Have proficiency with various computer applications such as Word, Excel, and PowerPoint, CTMS, eTMF required
• Have the ability to successfully manage people/project issues
• Have mature management skills demonstrated by calm and thorough review of situations
• Seek to understand all contributing factors
• Propose, implement, and evaluate appropriate, creative resolutions
• Demonstrate the ability to define and meet project requirements

Responsibilities

• Coordinate and manage 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)
• Oversee 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)
• Customize 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 guiding the CRA team
• Manage successful trial close-out, identifies critical activities to make timely and efficient close-out
• Be 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
• Provide information and input about planned activities and status to PM and attend Project Review Meetings if/when needed
• Conduct project co-monitoring (if required) & if needed temporarily conducts site management / monitoring in case of immediate need and lack of resources
• Coach/mentor 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
• Prepare and chair CRA calls and actively participate in internal trial team calls and client calls
• Oversee / attend CRA handovers as appropriate
• Serve as a site contact for protocol clarifications and subject enrolment if CRA unavailable
• Monitor and manage trial materials supplies ensuring Investigational Product and other trial supplies are shipped to sites
• Review data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff
• Oversee the process of protocol deviation and Trial non-compliance documentation, tracking and escalation
• Participate in the development of trial newsletters communication
• Request appropriate Clinical Operations staffing, workload and resources and report trial deliverables and resource needs
• Assist, where appropriate, the PM in discussions with clients on trial documentation issues or technical related documentation concerns that may arise
• Review 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
• Oversee eTMF status
• Review trial reports and analyzes trends to recognize risks, provides input into mitigation plans and implements mitigations belonging to clinical activities
• Contribute to optimization of trial processes to increase efficiency
• Coordinate and provide support for trial related (site) audits & inspections
• Contribute to corrective and preventive action plans where needed and ensures their timely implementation and closure
• Ensure project consistency within and across projects by following Allucent / relevant SOPs
• Assist and support in the preparation of various training material used by Allucent (including SOPs training, as well as specific trial related)
• Assist in the preparation and conduct of Kick-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested
• Prepare Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable
• Support 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
• Manage client expectations related to Clinical deliverables in accordance with contracted services and Allucent QMS
• Provide input into proposals when required
• Actively participate 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

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms