Fatima Boumares - Clinical Affairs & Evaluation Team Lead

Q: Where is Fatima based?

Fatima is based in Villecresnes, France .

Q: What languages does Fatima speak?

Fatima speaks the following languages: French (Native), English (Advanced) .

Q: How many years of experience does Fatima have?

Fatima has at least 15 years of experience. During this time, Fatima has worked in at least 7 different roles and for 7 different companies . The average length of individual experience is 2 years and 1 month . Note that Fatima may not have shared all experience and actually has more experience.

Q: What is Fatima's latest experience?

Fatima's most recent position is Clinical Affairs & Evaluation Team Lead at Leica Microsystems (Danaher Group) .

Q: What companies has Fatima worked for in recent years?

In recent years, Fatima has worked for Leica Microsystems (Danaher Group) , Becton Dickinson , and Merit Medical .

Q: Which industries is Fatima most experienced in?

Fatima is most experienced in industries like Healthcare , Biotechnology , and Pharmaceutical .

Q: Which business areas is Fatima most experienced in?

Fatima is most experienced in business areas like Research and Development (R&D) , Project Management , and Quality Assurance (QA) . Fatima also has some experience in Product Development .

Q: Which industries has Fatima worked in recently?

Fatima has recently worked in industries like Healthcare .

Q: Which business areas has Fatima worked in recently?

Fatima has recently worked in business areas like Research and Development (R&D) , Project Management , and Quality Assurance (QA) .

Recommended expert

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 including 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 nonclinical and preclinical tests such as biocompatibility, usability, 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, 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, CRA 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

Clinical Research Manager

Namsa

Jun 2010 - Nov 2015

5 years 6 months

Senior Clinical Research Associate

UBC CRO and CTI

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Healthcare (9 years), Biotechnology (5.5 years), and Pharmaceutical (5.5 years).

Healthcare

Biotechnology

Pharmaceutical

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Research and Development (14.5 years), Project Management (6 years), Quality Assurance (4.5 years), and Product Development (4 years).

Research and Development

Project Management

Quality Assurance

Product Development

Summary

Fatima holds University degree in Life Science with a major in Clinical Research. She has 15 years of experience in Clinical Development and Operations within corporate and startup companies. She started her career as a Clinical Research Associate in 2009 and moved to a project management role as Clinical Research Manager in 2015. Since the end of 2017, she has held Senior Manager roles within the Medtech as Clinical Leader, Field Clinical Manager and Clinical Affairs and Operations Manager.

Skills

Software

Clintrial
Access
Word
Excel
Powerpoint
Outlook
Lotus Notes
Edc System: Inform / Medidata Rave / Oracle Rdc
Ctms (Impact & Medidata Rave)
Emvr (Epharma Solution)
Argus Database
E-tmf (Veeva Vault)
Florence

Regulatory

Good Clinical Practice Gcp- Ich / 21 Cfr Part 11 / Gmp Annex 13 And Annex 11
Device Regulation: Iso 14155: 2020, Iso 13485: 2029, Iso 14971:2029 Risk Management
98/79/ce Medical Device Directive
Meddev 2.7/1
Medical Device Regulation 2017/745
Gdpr
21 Cfr Part 820 (Cgmp)
21 Cfr Part 812 (Investigational Device Exemptions)
Uk Mdr

Languages

French

Native

English

Advanced

Education

Oct 2011 - Jun 2012

Nice Antipolis University

Master (M1) of science of health Engineering · Science of health Engineering · Nice, France

Oct 2009 - Jun 2010

Pierre & Marie Curie University

Bachelor of Science Clinical Research · Clinical Research · Paris, France

Oct 2006 - Jun 2009

René Descartes University

Bachelor of Science Degree, Biology · Biology · Paris, France

Profile

Created

October 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Fatima based?

Fatima is based in Villecresnes, France.

What languages does Fatima speak?

Fatima speaks the following languages: French (Native), English (Advanced).

How many years of experience does Fatima have?

Fatima has at least 15 years of experience. During this time, Fatima has worked in at least 7 different roles and for 7 different companies. The average length of individual experience is 2 years and 1 month. Note that Fatima may not have shared all experience and actually has more experience.

What roles would Fatima be best suited for?

Based on recent experience, Fatima would be well-suited for roles such as: Clinical Affairs & Evaluation Team Lead, Clinical Affairs Project Manager, Clinical Project Manager.

What is Fatima's latest experience?

Fatima's most recent position is Clinical Affairs & Evaluation Team Lead at Leica Microsystems (Danaher Group).

What companies has Fatima worked for in recent years?

In recent years, Fatima has worked for Leica Microsystems (Danaher Group), Becton Dickinson, and Merit Medical.

Which industries is Fatima most experienced in?

Fatima is most experienced in industries like Healthcare, Biotechnology, and Pharmaceutical.

Which business areas is Fatima most experienced in?

Fatima is most experienced in business areas like Research and Development (R&D), Project Management, and Quality Assurance (QA). Fatima also has some experience in Product Development.

Which industries has Fatima worked in recently?

Fatima has recently worked in industries like Healthcare.

Which business areas has Fatima worked in recently?

Fatima has recently worked in business areas like Research and Development (R&D), Project Management, and Quality Assurance (QA).

What is Fatima's education?

Fatima holds a Master in Science of health Engineering from Nice Antipolis University, a Bachelor in Clinical Research from Pierre & Marie Curie University and a Bachelor in Biology from René Descartes University.

What is the availability of Fatima?

Fatima is immediately available for suitable projects.

What is the rate of Fatima?

Fatima's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.