Fatima B. - Clinical Affairs & Evaluation Team Lead

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Villecresnes, France

Experience

Nov 2024 - Aug 2025

10 months

Au, Switzerland

Clinical Affairs & Evaluation Team Lead

Leica Microsystems (Danaher Group)

Leading the Clinical Evaluation process, preparation of the Clinical Evaluation Plan, Clinical Evaluation report and Post Marketing Clinical Follow up plan and report.
Cross functional team work on NPI and product life cycle or engineering changes, collaborate with R&D, Product Managers and marketing to test the performance, safety, clinical benefit-risk for new product introduction to market or improvement.
Participate in the PMS (Post Marketing Surveillance) process and reporting.
Supporting the implementation of the EU MDR and ISO 14155:2020 requirements in the company processes and study documents (conducting a Gap Analysis).
Preparation and supporting the clinical development and regulatory strategy.
Preparation and participation to the accreditation audit for both EU and US offices, leading the clinical evaluation part of the audit.
Leading Clinical Operations team (3 Clinical Project Managers and 1 Regulatory Specialist).
Managing Clinical research programs, budget, resources, suppliers and deliverables.
Leading Post Marketing Clinical Follow up strategy to generate long term clinical evidence to maintain product in the market.

Oct 2021 - Oct 2024

3 years 1 month

Paris, France

Clinical Affairs Project Manager

Becton Dickinson

Design and methodology of clinical investigation study, reviewing literature to support study design and work with the biostatistician on the study design, objectives, endpoints, sample size calculation and statistical analysis plan.
Draft the clinical study documents (clinical study protocol, investigator brochure, ICF, clinical evaluation plan for device studies, annotated e-CRF).
Preparation of the study plans: project plan, monitoring plan, communication plan, data management plan in collaboration with data manager, and risk assessment plan.
Management of site feasibility and selection, review of site qualification reports.
Preparation of clinical investigation submission to competent authorities and ethic committees within EU countries, Switzerland, UK and US (FDA).
Preparation/review of the technical file / IMPD for submission purposes (including non clinical and preclinical tests such as biocompatibility, usability - human factors, stability, verification and validation, risk management file, preclinical or in silico tests).
Cross-function collaboration with biostatistician, data manager, regulatory affairs, quality assurance, R&D and safety to support the strategy and project delivery.
Selection and management of study vendors (CRO, core labs).
Managing the site initiation and study team training.
Management of the study conduct: supporting site management and enrollment, supervising the CRA team, reviewing and approving the site monitoring reports, supply management and safety management AE/SAE and device deficiency reports and preparation of the safety report (PSUR).
Management of protocol deviations or violations, non-conformities, and CAPA reports.
Identification of study / device risk and work with cross team to mitigate the risk under the risk management process.
Supervising the e-TMF maintenance and conducting a periodic TMF internal audit.
Management of site payment, vendor invoicing and the study budget.

Mar 2019 - Mar 2021

2 years 1 month

Paris, France

Clinical Project Manager

Merit Medical

Managing clinical operations including site identification, feasibility, selection, regulatory submission to EC/IRB and competent authorities, managing site contract negotiation, site initiation and training to the data cleaning and site close out, reviewing and approving site visit reports.
Managing cross functional team, CRAs, data management and biostatistics.
Managing study budget and site payments.
Clinical study device training: supporting the study cases in the Cath lab for endovascular devices.
Building relationships with KOLs and HCPs to facilitate communication and support the project deliverables.
Supporting the clinical affairs teams on field operational activities, investigator meeting, CRAs management, addressing any open action items with PI and sites.
Supporting clinical safety management AE/SAE and device deficiency and product compliance.
Working closely with marketing and sales to support any clinical topic or training on the device, indication and data evidence to support current and new customers.
Representing and presenting during the investigator meeting and attending congress.
Supporting clinical data review and presentation, working with KOL on paper and presentation during conference.

Nov 2017 - Feb 2019

1 year 4 months

Paris, France

Clinical Leader

Cellnovo Group

Leading the Clinical Affairs department activities and resources, planning the clinical premarket and post market projects, managing the data evidence generation on the insulin pump to support the reimbursement and market access in the EU countries.
Management of the artificial pancreas (automated insulin delivery system) program from R&D to the market, supporting the device development phases and risk management, planning the clinical programs and CE Mark dossier.

Feb 2017 - Nov 2017

10 months

Paris, France

European Clinical Field Specialist

Spectranetics

Clinical study device training: supporting the study cases in the Cath lab for endovascular devices in peripheral and coronary arteries interventions, building relationships with KOLs and HCPs to facilitate communication and support the project deliverables.
Supporting the clinical affairs teams on field operational activities, investigator meeting, CRA introduction, addressing any open action items and supporting clinical safety management AE/SAE and device deficiency and product compliance.

Dec 2015 - Feb 2017

1 year 3 months

Paris, France