Open To Work
Noémie Nkejabega
Namur
Summary
Results-driven clinical research professional with extensive experience in data utilization, accuracy, and software expertise to deliver exceptional feasibility services. Recognized for adaptability and effective collaboration within teams, consistently prioritizing tasks and enhancing communication to achieve impactful outcomes. Proven ability to thrive in dynamic environments, ensuring project goals are met with precision and efficiency. Committed to advancing research initiatives through innovative solutions and a strong focus on quality.
Overview
13
13
years of professional experience
Work History
Lead Clinical Analytics and Feasibility
iTeos Therapeutics
01.2021 - 01.2025
- Develop, implement and promote the role of Feasibility Manager at iTeos Therapeutics, a biotech company developing new immuno-oncology therapeutics for cancer patients.
- Create, implement and continuously evolve internal feasibility processes and methodology.
- Develope comprehensive benchmark libraries that streamlined access to critical data for feasibility assessments (activation timelines, recruitment rates, local standard of care, available treatment options,...).
- Utilize industry tools (e.g.: Citeline Informa, Global Data, TriNetX, ClinicalTrials.gov,...) to generate actionable insights effectively improving enrollment timelines.
- Collaborate and leverage insights cross-functionally: Medical Director, Clinical Scientist, Medical Science Liaisons, Regulatory Affairs, Competitive Intelligence, Biostatistics, CMC, Clinical Business Operations Manager, Clinical Operations Program Lead...
- Deliver robust feasibility analyses for Phase I-III clinical trials in various oncology indications (all comers, 1L mNSCLC, 2L mNSCLC, Multiple Myeloma, Head and Neck, Ovarian, Endometrial, Prostate, Liver, Renal,...) and obesity, enabling study teams to make informed decisions on protocol design, region/country/site selection and enroll according to timelines.
- Model trustworthy enrollment forecasts for planned studies as well as scenarios to support executive management strategic decision making on potential future studies.
- Monitor actual versus baseline forecast patient enrollment and trigger re-forecasting process with study teams when needed.
- Design study-specific feasibility questionnaires.
- Oversee CRO feasibility process until site selection.
- Support budget reviews and forecasts
Clinical Study Manager
iTeos Therapeutics
01.2020 - 01.2021
- Set up and lead the Study Team to meet clinical trial objectives.
- Lead CRO and vendor selection (create short-list, analyze RFPs, lead bid defenses, collect team feedback,...).
- Support sites contract review and negotiation.
- Identify risks and issues that may impact study delivery.
- Develop study systems/trackers.
- Oversee the development of clinical study documents such as study protocols, informed consent forms (ICFs) and regulatory files.
- Led cross-functional teams to ensure compliance with clinical trial protocols and regulatory requirements.
- Developed and implemented strategic plans for clinical study timelines, budgets, and resources.
Clinical Project Manager
Aepodia S.A.
01.2018 - 01.2020
- Full operational responsibilities for simple to complex early-phase clinical studies management in various indications (Influenza Vaccine, Alzheimer’s disease, stem cell therapy for Type 1 Diabetes Mellitus, oncology...) in a CRO.
- Mentored junior project managers, fostering professional growth and skill development.
- Achieved timely completion of all assigned clinical projects while remaining within budget constraints.
Clinical Study Manager
Bone Therapeutics S.A.
01.2014 - 01.2018
- Coordinate study-related activities of a European Phase 3, multicenter, randomized, double-blind controlled study to evaluate the efficacy and safety of a bone cell therapy
- Write and review study-related documentation (Protocol, ICF, Investigator’s brochure, Study Procedure Manuals, Development Safety Update Report (DSUR), SOPs, Monitoring Plan...).
- Design and develop Case Report Forms (CRF).
- Perform international Regulatory Ethics Committee submissions.
- Manage clinical trial agreements (preparation, negotiation and execution in accordance with budget).
- Perform investigational sites identification, selection, initiation and close-out, co-monitoring with CRAs.
- Build close relationships with investigational site staff.
- Organize and lead Investigator’s Meetings.
- Elaborate and implement strategies for patient recruitment.
- Manage activities and interactions with in-house CTAs, freelance CRAs, vendors and CROs (Imaging, Statistics, eCRF, Monitoring, PV).
- Lead the team of in-house Clinical Study Managers and Officers.
- Provide milestone information/clinical study status through weekly progress report to Head of Clinical Operations.
- Maintain excellent internal communication with the RA department, Production department, Logistics, QA/QC, Data Management.
- Ensure adherence to Protocol and ICH-GCP.
Scientific and Business Administration Officer
Bone Therapeutics S.A.
01.2012 - 01.2014
- Develop monthly strategic communications across the Company’s Scientific, Medical and Corporate domains.
- Manage the Intellectual Property portfolio.
- Support Investor Relations and Business Development initiatives
Education
PhD -
University of Edinburgh
United Kingdom01-2013
Masters - Biochemistry and Molecular and Cellular Biology
University of Namur
Belgium01-2008
Masters - Biological Sciences
University of Namur
Belgium01-2007
International Baccalaureate (IB) -
Red Cross Nordic United World College
Norway01-2002
Skills
- Analytical data utilization
- Strong focus on accuracy
- Effective team collaboration
- Prioritization and scheduling
- Service excellence
- Strong verbal communication
- Supportive interpersonal skills
- Flexible in dynamic environments
- Experienced in software utilization
Languages
French
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
Additional Information
Paper Art Lover
Family Trip Keen Organizer
2 Kids #1 Cheerleader
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Timeline
Lead Clinical Analytics and Feasibility
iTeos Therapeutics
01.2021 - 01.2025
Clinical Study Manager
iTeos Therapeutics
01.2020 - 01.2021
Clinical Project Manager
Aepodia S.A.
01.2018 - 01.2020
Clinical Study Manager
Bone Therapeutics S.A.
01.2014 - 01.2018
Scientific and Business Administration Officer
Bone Therapeutics S.A.
01.2012 - 01.2014
PhD -
University of Edinburgh
Masters - Biochemistry and Molecular and Cellular Biology
University of Namur
Masters - Biological Sciences
University of Namur
International Baccalaureate (IB) -
Red Cross Nordic United World College