Remote Senior Clinical Trial Leader

Summary

Join Allucent™ as a Clinical Trial Leader (CTL) and lead and manage clinical trial activities globally. You will oversee CRAs, coordinate trial planning and implementation, ensure deliverables meet timelines and budgets, and manage trial close-out. Key responsibilities include managing CRA activities, developing monitoring plans, reviewing documents, selecting investigators, and managing trial materials. The role requires 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, competitive salaries, professional development opportunities, flexible working hours, and remote/hybrid work options.

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 analyze 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