I am interested in positions in clinical research, epidemiology, data management and statistical data analysis but also in other domains of scientific research. I prefer a function with prospects, developing and putting in practice my skills. I have been working as Scientific/Medical writer at Emtex for 2,5 years and have mainly gained experience in writing different regulatory documents for vaccines (such as clinical trial protocols and related documents, clinical study reports, case narratives and quality control), communication with customers, organisation and time management. In addition, I have a scientific background with advanced knowledge in biostatistics. I am multilingual and able to work in a multidisciplinary team as well as independently. I also have other valuable skills like the sense of quality and accuracy, scientific rigor, interpersonal and communication skills, sense of duty, negotiation skills, and the ability to learn from the experience of others.
March 2014 --- September 2014
Responsible for coordinating the implementation of integrated surveillance system for sexually transmitted infections in Medical Homes and scientifically publish the research results
September 2011 --- February 2014
Scientific writing of clinical regulatory documents (protocols, clinical study reports, informed consent forms, tabular listings, narratives, ...) according to company standards (e.g. ICH, standard operating procedures, document templates, style guidelines) across a wide variety of therapeutic fields. Medical communications with clients, achieving timelines, quality control and review of clinical documents.
April 2005 --- August 2006
Supervision of fieldworks
Self-disciplineCharmStrivingDiligenceDependabilityPerspectiveOrientationAnger commandSelf-confidenceIndependenceAssertivenessSociabilityOptimismApproachabilityInterest in knowledgeAdaptabilityWillingness to compromiseKindnessOrganizationAttention to detail
Infectious diseasesInterpret clinical trial resultsClinical Data Management (CDM)Scientific WritingScientific methodologyClinical monitoring
Infectious diseasesPhysical medicine and rehabilitationSearch literature on clinical trialsInterpret clinical trial resultsInterpret systematic reviewsPhases of clinical development (phase I to IV)Developing Clinical Trial ProtocolsICH GCP guidelinesLife SciencesMultilingualTeamworkData ManagementEndocrinology and metabolismOphthalmologySports medicineRandomization and blindingPrinciples and ethics of clinical researchInformed Consent ProcessInformed Consent DocumentsDrug InteractionDrug Safety and PharmacovigilanceDrug metabolismScientific methodologySafety trialsEfficacy trialsGood Clinical Practice (GCP)It skillsClinical researchLifesciencesClinical trialsPharmaceutical IndustryICH-GCP
Skills and Expertise
Write protocolsAnalyze data/information to determine potential relationships.Conduct literature searches.Review the interpretation of dataConduct limited data and/or statistical analysis.Plan work to meet objectives and deadlinesInteract with statisticianscollaborate in research projects at universitiesRead medical literature to maintain current awareness and knowledgeEnsure good clinical practice (GCP)Approve the supply of formulated drug to outside clinicians who wish to conduct human studiesEdit dataAdverse event reporting
Extrapolate resultsEvaluate, review and assess protocols and amendments for subject safety and welfareAnalyze data/information to determine potential relationships.Capture pertinent data onto source documents (i.e., vital signs, adverse events, concomitant medications, etc.).Approve the supply of formulated drug to outside clinicians who wish to conduct human studiescollaborate in research projects at universitiesConduct limited data and/or statistical analysis.Create clinical project documents according to the protocolDevelop protocolsEdit dataEnsure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPsEvaluate, review and assess protocols and amendments for feasibility Conduct literature searches.Interpret dataPlan work to meet objectives and deadlineslifescienceWrite protocolsReview the interpretation of dataRead medical literature to maintain current awareness and knowledgePrepare sound articles for publicationInteract with statisticiansGenerate regulatory submissions through written reports, summaries or evaluations
Master's degree in Epidemiology, clinical research and Research on health services, Master of Public Health (MPH) from Université Catholique de Louvain, Belgium in 2009
Bachelor's degree in Physical Therapy/Therapist from Kigali Health Institute, Rwanda in 2004