Ali Lefebvre

• Direct and coordinate cross-functional project teams (Regulatory, Clinical Operations, Biometrics, Medical Affairs/Safety) to achieve milestones and deliverables.
• Manage study progress to meet client and organizational requirements while ensuring compliance with SOPs, policies, and regulatory standards.
• Control project budgets and scope, ensuring profitability and adherence to financial targets; managed budgets up to $25M.
• Oversee resource allocation to maintain timelines and meet project deliverables.
• Maintain effective communication and provide internal and external status updates, including monthly progress reports.
• Ensure project-related training compliance and adherence to standard processes across all tasks.

• Serve as primary operational liaison for sponsors, vendors, and third-party providers; ensure scope, timelines, and KPIs are achieved.
• Lead planning and execution of clinical trials, including protocol development, amendments, study manuals, and project timelines.
• Oversee trial start-up, site qualification, monitoring, and close-out activities while ensuring compliance with GCP, ICH, SOPs, and regulatory requirements.
• Manage informed consent development, regulatory submissions, and interactions with Central IRBs.
• Monitor study progress through CTMS, review monitoring reports, and track site action items; resolve data queries and maintain trial master file.
• Control study budgets, forecasting, and risk mitigation strategies; provide operational status reporting to stakeholders.
• Facilitate sponsor and internal team meetings, driving accountability through action item tracking and process consistency.

Clinical/Data Manager & EDC Designer

• Act as primary operational contact for sponsors, vendors, and third-party providers; oversee scope, timelines, and KPIs to ensure successful project delivery.
• Plan and execute clinical trials, including protocol design, amendments, study manuals, and project-specific plans; manage start-up through close-out.
• Provide oversight of cross-functional teams and study activities to ensure compliance with GCP, ICH, SOPs, and regulatory requirements.
• Manage study budgets and forecasting while implementing risk mitigation strategies.
• Lead sponsor and internal team meetings, track action items, and ensure timely completion of deliverables.
• Review CRFs, data listings, and databases for protocol compliance; resolve data queries and maintain trial master file and CTMS.
• Contribute to development of clinical documents and patient recruitment strategies; mentor junior staff and support process improvements.
• Design and configure Mednet eCRFs, edit checks, derivations, integrations, and reports based on protocol requirements.
• Lead eCRF design and review meetings; administer user roles, reports, and site access.
• Provide technical and user support, conduct end-user training, and troubleshoot system issues.
• Collaborate with sponsors and vendors on testing and deployment; ensure timely resolution of technical challenges.
• Participate in development and maintenance of Data Management SOPs and system specifications.

• Serve as primary contact for assigned sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
• Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
• Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
• Liaise with the CTA and CRA to distribute and track clinical trial supplies, e.g. CRFs, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
• Facilitate translation and back translation of all necessary documents, as appropriate for local country requirements.
• Assemble files and ensure documents for the sponsor file are in place, ensuring that all relevant study documentation is present for study sites and are accurately reflecting the progress of the study.
• Track and process enrollment, site status, IP distribution/destruction, protocol deviations, adverse events (AEs)/serious adverse events (SAEs), missing pages, data queries

• Documenting and tracking study activities using relevant forms and tools, as well as relevant project management system with guidance/support.
• Assist in the preparation of study site files in accordance with relevant SOPs.
• Create and maintain contact list of study team members, study sites, and external suppliers/contract organizations.
• Assist with minute taking and documentation for sponsor/external or internal teleconferences.
• Assist in setting up and maintaining tracking systems for e.g. study supplies and investigator payments.
• Assist in the tracking and filing of documents for all clinical studies into Chiltern’s global database.
• Perform other duties as required by the department or project team.
• Liaise with all other Chiltern departments to ensure the smooth running of the study.