Passionate in the field of Clinical Research and people/team management with large experience as Team Leader/Manager at INC Research and predecessor entities (Kendle Int., Charles River Laboratories, Inveresk Research, Clintrials Research), from selection/recruitment of candidates to the line management of up to 20 in house CRAs on international level. 14 years of experience in clinical research: 7 years in the monitoring field, 7 years in the management field.
Clinical Team Leader/Clinical Operations (iCRA) Manager, Central/Remote Monitoring
November 2012 --- July 2016
Direct supervision of in house CRAs in Europe and India: - Responsible for the management of performance, growth and professional development of in house CRAs across Europe and India, having managed up to 20 employees over the last 4 years. - As a hiring manager, completed justification for hire, reviewed CVs, conducted interviews and collaborated with recruitment to generate offer letters. - Employee induction and orientation - Established performance standards: Regular review and conduct of formal performance reviews and recommendations for salary increases, promotions and employee award initiative programme. - Promoted an environment in which associates demonstrated commitment to quality, professionalism and customer service. - Allocated project resource for EU and US, maintaining short and long-term overview of allocations: Ensured a balanced distribution of workloads, focusing on matching staff development opportunities. - Ensured consistency, training and communication, adhered to training guidelines along with identifying and addressing individual and corporate training needs. - Organised and attended meetings via Cisco Web-ex. - Employee holiday, sick leave, recuperation and expense monitoring and approval. - Metric and Business Goal focused, analysed direct reports metrics and ensuring targets were achieved and exceeded. - Creation of a training on direct & indirect communication + guidelines on good communication skills and provided training. - Exceptional use of judgment and ability to solve problems efficiently. - Comprehensive knowledge of Microsoft Word, Outlook, Lotus Notes, Excel and PowerPoint - Project Oversight - Interacted with Associates and project teams to ensure timely site initiation, resolution of process improvements, budget oversight and ensured effective communication, quality and consistency was maintained to ensure project deliverables were met.
Project Coordination Services (in house CRA) Manager
June 2011 --- October 2012
Responsible for the management of performance, growth and professional development of In-house Clinical Research Associates across Europe and India. - Allocated project resource across Europe and US. Maintained short and long-term overview of allocations, addressed any under or over utilisation issues. - Ensured consistency, training and communication within project teams, adhering to training guidelines along with identifying and addressing individual and corporate training needs. - Assumed responsibility for the co-ordination of recruitment in Europe and defined objectives for direct reports, regular review and completion of formal performance review every year. Made recommendations on salary increases and promotions. - Thorough understanding of ICH/GCP, regulatory requirements and the Clinical Research process, ensuring work is conducted in accordance to company policies and SOPs.
January 2007 --- January 2010
Line management of Project Assistants: performance review, yearly appraisal, timesheet review/approval, coaching & mentoring, etc.
Lead in house CRA
January 2006 --- January 2007
Lead iCRA on various clinical studies, review and negotiation of investigator contracts, mentoring/coaching, sponsor contact, site management, etc.
Project Assistant - in house CRA
January 2001 --- January 2006
- Management of 40 French sites on phase IIIb HIV study: from PSSV to COV (remotely), ISF preparation, translations, contract negotiation, AE/SAE follow up and reporting, CRF review, query resolution, etc. - Provided in-house support and assistance to assigned projects. Having the opportunity to work on an ethics submission project. - Trained and mentored Project Assistants into their roles. - All local office translation coordination (internally and externally)
SAP Glossary Specialist
January 1999 --- December 2000
Translation of standard sentences for MSDS (English French Spanish) and coordination of translations in other EU languages. Update of the SAP system to prepare MSDS.
ApproachabilityAttention to detailAuthenticityCollaborationCoordinationEfficiencyIndependenceInnovative thinkingInterest in knowledgeOrganizationProactivityProblem solvingResult OrientedSelf-disciplineTrust
Adverse Events (AE)Clinical monitoringClinical operationsClinical researchClinical Trial Management System (CTMS)Clinical trialsCoachingCommunication SkillsCompliance with regulationsContinuous ImprovementContract negotiationCRFCROCustomer ServiceData AnalysisData entryData cleaningDrug development processeCRFEDCForecastingGood Clinical Practice (GCP)ICH guidelinesIVRSLeadershipMicrosoft OfficeMonitoring Study ProgressMultilingualOperations Managementpeople managementPhases of clinical development (phase I to IV)Problem SolvingProcess improvementProject CoordinationQuality Control (QC)RecruitingRegulatory submissionsReport WritingSerious Adverse Event (SAE)Standard Operating Procedure (SOP)Supervising CRAsTeam LeadershipTeam ManagementTeamworkTime ManagementTrainingTranslationStudy protocols
Skills and Expertise
Build and manage the Trial Master File (TMF) Interact with nurses Interact with physicians Monitor a clinical study Report dataAct as the main line of communication between the sponsor and the investigatorAdminister supply requestAdverse event reportingAnalyse growth / improvement potentialApprove monitoring reportsArchive study documentsAssist study siteAssist with proceduresAttend investigator meetingCoach and provide guidance to clinical staff.Collaborate with project teamCollect dataCollect financial data from hospitalsCommunicate effectively on different company levelsComplete study proceduresConduct close-out visitsConduct site initiationcontrol different protocol versions and other essential documentsCreate study documentsCreates a collaborative team environmentData entryDevelop training materialsDistribute study documentsDocument employees training requirementsEnsure data consistencyFollow up training programsFollow-up of external auditsFollow-up of internal auditsInteract with pharmacistsLead studiesLead teamsManage projects resourcesMonitor dataMonitor Key Performance Indicators (KPI's)Observe trends in dataPeople managementPlan work to meet objectives and deadlinesPrepare regulatory documentsProvide study site fileProvide trainingRegulatory submissionsReport serious adverse events (SAE)Resolves queriesRespond to audit findingsReview monitoring reportsSchedule trial visitsSite managementSolve problemsSupervise clinical monitorsUpdate Clinical Trials Management System (CTMS) Control dataAssign activitiesClinical data collectionCoach staffCompile informationControl protocol versionsDirect co-workers to achieve resultWork collaboratively with the other members of the clinical research team
Master's degree in Scientific and Technical Translation from Institut Libre Marie Haps in 1998