Remote Clinical Trial Leader

Summary

Join Allucent as a Senior Clinical Trial Leader (Sr. CTL) and lead the clinical research associates in day-to-day activities, manage study start-up, critical documentation collection, and monitoring plans. Develop patient recruitment and retention plans, conduct project co-monitoring, and oversee trial close-out.

Requirements

• A bachelor's degree in life sciences or nursing qualification preferred
• A minimum of 6 years clinical research experience with at least 2 years CTL or CTM
• Ability to mentor and train other CRAs in a positive and effective manner
• In-depth knowledge of clinical trials and the critical elements for success in clinical trials
• Strong therapeutic background
• Possesses experience and knowledge in the CRO industry that will support management of clinical trials
• Demonstrates the ability to successfully manage people/project issues
• Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions
• Demonstrates the ability to define and meet project requirements
• Demonstrates flexibility for improvement and creating solutions
• Proven organizational abilities, and excellent written and oral communication skills
• Excellent team player with team building skills
• Strong customer focus

Responsibilities

• Manage the study start up in collaboration with PM, Regulatory Lead and, if applicable, Global Site Activation Manager (GSAM)
• Coordination and oversight of Critical documentation collection, maintenance and filing
• Preparing Monitoring Plan; providing input to TMF Plan and to other study plans. Ensure all plans are implemented
• Contributes to the development of CRF guidelines and edit checks
• Customizing Site Visit Report checklists/templates and their annotated versions according study specific requirements
• Develop or modify templates to be used for monitoring activities according to study 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 CRMs/COMs
• Coordinate and manage site visit schedules
• Manages CRA site assignments and schedules
• Develop patient recruitment and retention plans
• Provide information and input about planned activities to PM for the regular Project Review Meetings and attends Project Review Meetings if needed
• Conducts project co-monitoring (if required) and team training
• Site contact for protocol clarifications and subject enrolment if CRA unavailable
• Monitor and manage trial materials supplies. Ensures Investigational Product and other study 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 documentation, tracking and escalation
• Participates in the development of study newsletters communication
• Relays project status and issues to PM
• Requests through the PM appropriate Clinical Operations staffing, workload and resources and reports study deliverables and resource needs
• Assists, where appropriate, the PM in discussions with clients on study documentation issues or technical related documentation concerns that may arise
• Reviews study 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
• Coaches/mentors CRA team
• Develops and delivers project-specific training and provides input to Project Specific Training Matrix
• Ensures project consistency within and across projects by following SOPs
• Assists and supports in the preparation of study specific training matrix and various training material (including SOPs training, as well as specific-therapeutic area related). Assists and supports web based training material preparation. Assists when needed in the preparation of company and scientific/medical presentations to potential clients and at Investigators’ meetings and other committees’ meetings as requested
• Assists in revision of Site Budgets and manages Investigator and Site Payments
• Contributes to case management and timely closure
• Supports PM in the management of study vendors as required
• Provides input into proposals when required
• Actively participates in preparation, attendance and presentation of bid defense or any other study related meetings

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 enriching 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
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees