Ismahane Moulay Lakhdar

• As a Clinical Project Manager, I lead feasibility, performance, and post-market trials for the FocalOne medical device, ensuring each phase meets scientific and regulatory standards. Starting with a detailed assessment of scientific feasibility, I work closely with investigators, as well as QA, R&D, and Marketing teams, to evaluate resources. I then coordinate the project team, overseeing budgets, timelines, and execution to drive the study’s success.
  Key responsibilities include:
  -Lead discussions and working groups to refine project methodology and logistics.
  -Draft and validate essential study documents, including the study protocol, informed consent forms, investigator brochure, and CRFs.
  -Select and qualify investigator sites and participants in collaboration with coordinators to ensure alignment with study objectives.
  -Preparing regulatory submissions to the ANSM and the CPP and managing responses to any questions raised by these regulatory bodies.
  -Supervise financial agreements and contracts with investigators for budget and timeline management.
  -Conducting Site Initiation Visits (SIVs).
  - Coordinate study activities to ensure adherence to protocols, budget, and deadlines.
  -Develop and execute the monitoring plan in collaboration with the project team, oversee logistics (medical devices, consumables, documentation), and maintain traceability within investigator sites.
  - Monitor adverse events in collaboration with Materiovigilance teams, manage the Trial Master File (TMF), and organize investigator meetings.
  -At study close, ensure proper site closures, complete all documentation, and regulatory archiving, while contributing to post-study reporting and follow-up activitie

• As a clinical research consultant, I was engaged in several specialized assignments. The first involved working as a Clinical Project Manager focused on biological studies, as described below. In the second assignment, I took on a key role in supporting the completion of a comprehensive database for a post-market study for a dental medical device manufacturer. This mission was essential to ensure data accuracy and regulatory compliance, contributing to the overall quality and success of the study by providing insights into device performance and patient outcomes in real-world conditions.

• As a Clinical Project Manager specializing in biological studies in lymphoma research, I managed all phases of clinical trials, overseeing planning, resource coordination, timelines, and budgets to ensure smooth project execution. My responsibilities included drafting detailed protocols for both ancillary studies and the biological components of main trials, ensuring compliance with scientific, regulatory, and GDPR standards. I developed informed consent forms with a focus on data protection, particularly for sensitive genetic information, and created e-CRFs and laboratory manuals to support accurate and compliant data collection across all study sites. Key responsibilities included:
  
  -Leading discussions and coordinating with cross-functional teams, including investigators, laboratory staff, and clinical teams, to refine project methodology and logistics for biological sample management.
  -Drafting and validating essential study documents, including protocols, consent forms, laboratory manuals, and e-CRFs.
  -Selecting and qualifying laboratory sites in collaboration with coordinators to ensure alignment with study and biological sample handling objectives.
  -Managing budgets and timelines for the biological aspects of the study, overseeing financial agreements and contracts related to sample processing and storage.
  -Coordinating the collection, transportation, and storage of biological samples, ensuring adherence to protocols, timelines, and regulatory guidelines in collaboration with CRA monitors.
  -Developing and executing the logistics for biological materials (samples, reagents, documentation), and ensuring traceability within lab sites.
  -At study close, overseeing the proper storage or disposal of samples, ensuring complete documentation, regulatory archiving, and contributing to post-study reporting and analysis.

• As a Clinical Research Associate (CRA) Monitor, I was responsible for monitoring clinical studies sponsored by the Hospices Civils de Lyon (HCL). My primary focus was on oncology, cardiology, and pediatric studies, where I ensured compliance with regulatory standards and protocol requirements across various study sites.
  Key responsibilities included:
  -Performing On-Site Monitoring Visits: Regularly assessing site adherence to protocols, verifying data accuracy, and ensuring patient safety in alignment with Good Clinical Practice (GCP) guidelines.
  -Pharmacy Monitoring: Verifying the proper storage, handling, and dispensing of study medications at each site, ensuring compliance with protocol requirements and pharmacy regulations.
  -Managing Site Communication and Training: Serving as the main point of contact for site personnel, providing ongoing training and support to maintain compliance with study protocols and regulatory standards.
  -Assessing and Reporting Adverse Events: Ensuring all adverse events (AEs) and serious adverse events (SAEs) were promptly documented and reported to the sponsor and regulatory authorities.
  -Conducting Site Close-Out Visits: Confirming the proper completion of study documentation, resolving any outstanding queries, and overseeing the final archiving of essential documents.

• As a Clinical Project Manager in pediatric neurosurgery and genetics, I managed the entire lifecycle of complex clinical studies, from initial planning to completion, ensuring full compliance with scientific and regulatory standards. My role included both strategic oversight and hands-on management, working closely with INSERM research laboratories, biological resource centers, and various hospital departments to facilitate seamless study execution. Additionally, I responded to research funding opportunities by preparing grant applications to secure essential financial support for hospital-based studies. Key responsibilities included:
  - Drafting study protocols, informed consent forms and patient information sheets.
  - Coordinating Multidisciplinary Collaboration with INSERM labs, biological resource centers, and hospital departments to align on study milestones, objectives, and timelines.
  - Overseeing the collection, storage, and transport of biological samples to ensure integrity and traceability.
  - Overseeing contract negotiations and agreements with research partners.
  - Managing timelines, budgets, and resources; preparing and submitting grant applications for hospital research funding to secure essential financial support.

As a Clinical Research Associate in pediatric studies, I supported the operational aspects of clinical research, focusing on data collection, patient follow-up, and ensuring protocol adherence across all study phases. Working closely with the project manager and coordinator, I helped ensure high-quality data and patient-centered care in a regulated research environment.

Key responsibilities included:

-Support the preparation and revision of study protocols and information sheets, ensuring consistency with clinical objectives and regulatory guidelines.
-Collecting, verifying, and accurately entering patient data into Case Report Forms (CRFs) and electronic data capture systems, ensuring compliance with study protocols and data accuracy.
- Assisting with patient recruitment, scheduling follow-up visits, and coordinating with families to provide study information and address questions, promoting a positive and informed patient experience.
- Monitoring patient visits to ensure protocol adherence, documenting deviations when necessary, and working with clinical teams to maintain Good Clinical Practice (GCP) standards.
-Supporting the collection, labeling, and transport of biological samples, following proper protocols to maintain sample integrity and traceability.
-Ensuring that all study documentation is up-to-date, complete, and accurately maintained, including patient records, study logs, and regulatory binders.
-Working closely with physicians, nurses, and research coordinators to facilitate smooth study operations, aligning on timelines and tasks to ensure comprehensive patient care.

• As a Clinical Research Technician (TEC) in pediatric studies, I supported the operational aspects of clinical research, focusing on data collection, patient follow-up, and ensuring protocol adherence across all study phases. Working closely with multidisciplinary teams, I helped ensure high-quality data and patient-centered care in a regulated research environment.
  
  Key responsibilities included:
  
  -Collecting, verifying, and accurately entering patient data into Case Report Forms (CRFs) and electronic data capture systems, ensuring compliance with study protocols and data accuracy.
  - Assisting with patient recruitment, scheduling follow-up visits, and coordinating with families to provide study information and address questions, promoting a positive and informed patient experience.
  - Monitoring patient visits to ensure protocol adherence, documenting deviations when necessary, and working with clinical teams to maintain Good Clinical Practice (GCP) standards.
  -Supporting the collection, labeling, and transport of biological samples, following proper protocols to maintain sample integrity and traceability.
  -Ensuring that all study documentation is up-to-date, complete, and accurately maintained, including patient records, study logs, and regulatory binders.
  -Working closely with physicians, nurses, and research coordinators to facilitate smooth study operations, aligning on timelines and tasks to ensure comprehensive patient care.

• - Literature Review and Scientific Article Analysis: Conduct thorough scientific literature reviews on the latest advancements in leukemia and anticancer treatments, analyze research articles to identify new approaches and methodologies, and summarize key findings to guide study directions.
  -Cell Culture: Prepare and maintain cancer cell cultures under controlled conditions, ensure the viability and purity of cell lines, and conduct cytotoxicity assays to assess the effects of anticancer compounds in vitro.
  -In Vivo Preclinical Studies: Develop and implement animal study protocols to evaluate the efficacy of anticancer drugs in mouse models, including monitoring tumor progression, administering treatments, and collecting data.
  -Analysis of Anticancer Drug Effects: Assess the effectiveness of anticancer compounds by observing biological responses in treated mice (tumor growth, survival, toxicity), and analyze biological samples to measure response markers.
  -Data Collection and Experimental Analysis: Perform statistical analyses on collected data, interpret findings to draw conclusions on the therapeutic effects of treatments, and prepare detailed reports of results.

• -Literature Review and Scientific Analysis: Conduct scientific research on DSB repair mechanisms and the effects of radiotherapy, analyzing relevant publications to identify methodologies and key biomarkers.
  -Cell Preparation and Culture: Establish and maintain human cell cultures under controlled conditions, including the preparation of specific cell lines for radiotherapy tests, ensuring cell viability and sample purity.
  -Cell Irradiation: Use radiation sources to expose cells to specific doses of radiotherapy, following strict protocols to simulate treatment conditions and induce double-strand breaks.
  -DSB Repair Analysis: Perform analyses on DNA repair mechanisms post-irradiation, using techniques such as immunofluorescence to detect repair foci and PCR to assess DNA changes.
  -Data Analysis and Interpretation of results to assess cellular responses to radiotherapy, and identify repair markers.