Clinical research Director with 17 years of experience in multinational and start-up organizations. dynamic, entrepreneurial, innovative, skilled at managing both projects and people. strong Project Management skills. able to motivate a team towards achievement of objectives, excellent Communication and Negotiation skills. experience in operating in complex matrix organizations. developed kol network and drove medical affairs initiatives through my Career.
industry: pharma, Medical Device, biotech
Director Clinical Research MaastrichtSeptember 2011 --- June 2014
- managed the crdm (cardiac rhythm disease management) Clinical research department (40 headcounts for successful delivery of pre- and post-market clinical programs and related Publications: 100% of trial and publication objectives achieved on time and within allocated budget. Therapeutic Areas: heart failure, tachy, brady, Diagnostic.
- led local we/mea/cee cardiac and Vascular group task force (structural heart disease, coronary and crdm) in order to ensure clinical and economic evidence was aligned between geographies and strategic business units.
- Planning and full accountability for the crdm clinical annual operating plan and quarterly forecasts/accruals with less than 1% actual versus plan variance.
- managed the evidence lifecycle from science)" rel="nofollow">Protocol design to evidence dissemination and supporting medical affairs activities through emea.
- in collaboration with Sales & Marketing, led site and Investigator selection for Clinical Trial nominations, scientific advisory boards, steering committees, co-organized congresses, symposia and field force trainings.
- built and maintained strong key opinion leaders network.
- ensured strategic and scientific alignment of the crdm external research programs (Physician initiated projects) and close tracking of their execution.
ResiliencyWillingness to compromiseCompetitivenessOrganizationSelf-disciplineCreative thinkingPerspectiveSociabilityOptimismAssertivenessSelf-confidenceStriving
Search literature on clinical trialsInterpret clinical trial resultsClinical trial designDrug development processStudy outcomes and outcome measuresDeveloping Clinical Trial ProtocolsPrinciples and ethics of clinical researchICH GCP guidelinesEthics submission and approval processInformed Consent ProcessInformed Consent DocumentsProject ManagementClinical trial budgetingWriting Study Procedures and SOPsMarketing approvalGood Clinical Practice (GCP)Understanding of regulatory guidelinesCardiovascular diseasesHematologyMedical oncology Diagnostic radiologyNuclear radiology Radiation oncologyVascular surgeryUnderstand levels of research evidence
Skills and Expertise
Act as the main line of communication between the sponsor and the investigatorAdvise company lawyers, marketers and non-medical scientists on medical perspectives Approve suitability of patient information and consent documentsassess operational feasibility and recommend study execution planassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign, coordinate and supervise day-to-day activities of clinical study monitorsAttend at steering committee meetingsWrite protocolsWrite final medical reports based on the physician's evaluationlifescienceConduct literature searches.control different protocol versions and other essential documentsCoordinate approval of new study agreements and contracts.Coordinate with the ethics committeedevelop and manage comprehensive study timelines and metrics;attend Investigator meetings requiring travel and report pertinent information back to research team members.Attend seminars, courses and meetings within and outside the companyCoach and provide guidance to clinical staff.Calculate timelines for conducting and completing the trialDevelop a clinical strategy to bring a next drug or indication forwardCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Create clinical strategies for developing investigational drugs to the point of market approvalOrganise the steering committeeCreate clinical project documents according to the protocolCreate clinical strategies for post-marketing surveillance studies and new indications of marketed drugsDesign the studyDesign, conduct and evaluates post-marketing surveillance and other studiesDevelop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials Develop protocolsdevelop the study budgetDirect co-workers to achieve resultIdentify and provide training to trial team and associated staffEnsure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPsensure audit-ready condition of clinical trial documentation including central clinical files;generate Clinical Trial Report and manuscript for publicationIndentify, meet, interview and persuade investigators to conduct clinical trialsIdentify site issues and initiates correction plans based on monitoring reports.Initiate clinical trials Interface with CROs and other contractors with guidance in order to implement clinical trial programs efficientlyInteract with regulatory agenciesInteract with physiciansInteract with statisticiansLead round-table discussions with clinical investigators, monitors and consultantsLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredmanage study budget and maintain it within financial goalsNetwork with sponsors for potential trialsOversee outsourced data management activitiesParticipate at meetings with regulatory authoritiesParticipate in meetings with sponsors, monitors and regulatory authorities, as necessary.Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.Plan and coordinate regular advisory board and steering committee meetings.Plan work to meet objectives and deadlinesProvide general office management to keep operations running smoothly.Work with the PI to manage the day-to-day activities of the study including problem solving and protocol management.Work collaboratively with the other members of the clinical research team Understand and react to the internal politics and demands of the companyTrain off site staff to trial specific and industry standards.Support oral and written presentations of clinical results by study investigators.review vendor reports, budgets, and metrics; Review marketing adevertisments and promotional materials
MBA in from Solvay Business School in 2009
Post-university degree in Marketing Management in from ICHEC in 2003
Bachelor Medical Biology in from UCL, Institut Paul Lambin in 1996