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Rania LAMRANI

MARSEILLE

En résumé

Email : mandulisrl@gmail.com

Management d'études cliniques internationales (médicament, matériel médical) de la faisabilité à la remise du rapport final (mise en place, suivi opérationnel, analyses statistiques, rédaction de rapports et d'articles scientifiques). Expérience similaire en management d'études animales (matériel médical).

Clinical Project Management (drugs and medical devices) from feasibility, budget management to final report : Feasibility assessment, project design, definition and implementation of tasks, costs, resources (MS Project), budget management (from study level to department level), management of external vendors, operational management, statistical analysis, clinical study report, publication.

Team co-ordination and management (local and international) : Optimization of resources, team leading by sharing competencies and creating new challenges, high level of communication.

Scientific skills : Ability to make a link between the final deliverable and the scientific requirements, constant update on the last clinical guidelines, references, publications, attendance to medical congresses.

Communication skills : Within the project team, with Key Opinion Leaders and external vendors, through writing up of scientific documentation and investigator meeting organisation.

Adaptability : Ability to understand all scientific topics and therapeutic areas. Ability to play with several concomitant projects. Adaptation regarding the human and organisational environment, particularly the international environment.

Technical skills :

• Languages :
- English : proficient, main professional language
- French : mother tongue
- German : academic level

• Data processing :
- Softwares : MS Office (Word, Excel, MS Project,...), SAS / SPSS (statistics), Harvard Graphics, Impact / DLB / Climon (clinical trials), Guard (pharmacovigilance),Pfizer specific systems
- Multi-media : internet for professional and personal use (Medline, Biopharm, Trialtrove, CT.gov...).

• Therapeutic areas : auto-immune disease, cardio-vascular,oncology, respiratory, interventional, central nervous system, gastroenterology, organ transplantation, metabolism diseases, infectious diseases, well-being

English public profile on LinkedIn : http://fr.linkedin.com/pub/rania-lamrani/3b/354/534

Mes compétences :
Clinical Research
International
Médical
Research
writing

Entreprises

  • Université Aix-Marseille - DIU-FARC-TEC - Speaker

    2010 - maintenant Activity in parallel with my Project Research Manager position with i3 Global.

    Speaker for the French diplôma (Diplôme Inter-Universitaire de Formation des Assistants de Recherche Clinique et des Techniciens d’Etudes Cliniques / Inter University diplôma of Clinical Research Associates and Clinical Trial Technicians Training)
    Teacher of the following courses :
    - Clinical Research and Private Sponsors
    - Global Overview of Clinical Research

  • I3 Global - International Project Research Manager

    2010 - maintenant Outsourced as International Project Manager for Pfizer Ltd (International Head Offices) in the Functional Service Provider model.

    - Coaching and mentorship of study managers.
    - Coordinate the activities and deliverables of all study conduct partners (SMs, U.S. region & Affiliates, Pharm Sci, Vendors) to ensure timely delivery of quality data on one or more studies.
    - Oversee U.S. region & Affiliates to ensure that protocol and Monitoring Plan are consistently and appropriately implemented across investigator sites and countries.
    - Proactively identify and resolve study operations-related issues as they arise.
    - Responsible for ensuring that the operational aspects of a clinical study meet time, quality & cost targets consistent with the Clinical Development Plan.
    - Responsible for ensuring that studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; responsible for study management components of inspection readiness for all aspects of the study conduct.
    - Assist Clinical Protocol Manager (CPM) to develop project plans and implement resource strategies to achieve team’s project goals, including contingency planning and risk mitigation strategies, to ensure successful delivery of study goals.
    - Support the efficient implementation and utilization of globally agreed, processes, technologies and strategies (IVRS, etc).

    Home-Based status.

  • I3 Global - Internationl Study Manager

    2007 - 2010 Outsourced as International Study Manager for Pfizer Ltd (International Head Offices) in the Functional Service Provider model.


    • Coordinate the activities and deliverables of all study conduct partners (Study Managers, Country Offices, Pharm Sci, Vendors) to ensure timely delivery of quality data on one or more studies.
    • Oversee Country Offices to ensure that Protocol and Monitoring Plan are consistently and appropriately implemented across investigator sites and countries. Collaborate with the Country Offices to ensure they are provided with the information to effectively contribute to the study.
    • Proactively identify and resolve study operations-related issues as they arise.
    • Responsible for ensuring that the operational aspects of a clinical study meet time, quality & cost targets consistent with the Clinical Development Plan.
    • Responsible for ensuring that studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; Responsible for study management components of inspection readiness for all aspects of the study conduct.
    • Assist Clinical Protocol Manager (CPM) to develop project plans and implement resource strategies to achieve team ’ s project goals, including contingency planning and risk mitigation strategies, to ensure successful delivery of study goals.
    • Support the efficient implementation and utilization of globally agreed, processes, technologies and strategies (e.g., SDVSS, IVRS, etc).

    Home-Based status.

  • Datascope - InterVascular - Clinical Affair Specialist

    2001 - 2007 Medical device company developing main products in cardiovascular (vascular graft, stent, stentgraft, intra-aortic balloon pump ...). In charge of all Clinical Affair Department activities from department budget management to direct study related management.

    - Managed animal and clinical, pre-marketing and post-marketing studies in accordance with international regulations and recommendations (including GLP, GCP, ICH, ISO)
    o Preclinical and clinical design development
    o Managed projects including costs, resources, and time evaluations
    o Protocol elaboration
    o Managed external vendors
    o Follow-up of studies
    o Statistical analyses
    o Final report writing
    o Publication article writing
    - Scientific support for the other departments (marketing, sales, regulatory, R&D.

    Office Based.

  • BYK FRANCE LABORATORIES (Altana) - Senior Clinical Research Associate

    1999 - 2001 - In charge of implementation, monitoring and closure of international multicenter clinical trials
    - Identified new investigators in pneumology area

    Home-Based status, in charge of South-Eastern French sites.

  • ESCLI (CRO, now Kendle Intl.) - Clinical Research Co-ordinator

    1996 - 1999 Outsourced to Pharmaceuticals, or central management of clinical trials from Escli's offices

    • Outsourced in the sponsor’s offices (Rhône-Poulenc Rorer / now Aventis, International head offices) :
    - Budget management of the oncology department (main duty)
    - Co-ordination of affiliates in an international compassionate use program in colorectal cancer
    - Pharmacovigilance Associate in oncology
    • Outsourced in the sponsor’s offices (Novartis-Pharma - France)
    - International phase III clinical trials in breast cancer, renal and hepatic transplantations
    - International pivotal phase II clinical trial in hypercholesterolemia
    - International phase II trial in dermatology
    • Projects driven from CRO’s offices
    - Monitoring of an international phase II clinical trial in Belgium in hepatic transplantation on children and adults (for Omrix Biopharmaceuticals)
    - Co-ordination of a local phase III clinical trial (56 centres, 200 patients, 3 field monitors) in antibiotherapy / pneumology (for Rhône-Poulenc Rorer, now Aventis)
    - Clinical report drafting in accordance with ICH guidelines (for Cassene Laboratories.

    Office Based.

  • SCHERING-PLOUGH - Clinical Research Associate

    Hérouville-Saint-Clair 1995 - 1996 Managed 2 phase IIIb multicenter clinical trials in breast and lung cancers, total amount of 42 centres:
    - Field monitoring
    - Administrative tasks (including ethic committees, health authorities, contracts)
    - Budget management
    - General follow-up including CRO relationships, organisation of investigators meetings.

    Office Based.

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