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Summary

 

Project management & leadership

-            Build on national and international expertise in planning, implementation and oversight of effective delivery of clinical studies from Phase I through Phase IV

-            Seek continually for opportunities to build relationships and implement partnerships with key opinion leaders, in line with the development plans, marketing and business needs

-            Write, provide input and coordinate the development of study protocols and other study documents

-            Steer cross-functional internal and external teams

-            Coach of up to 10 team members

-            Develop, discuss and control global study budgets, patient recruitment & contingency plans

-            Report to line management and perform annual review of team performance

Pharmacist with large clinical research expertise in

-            Different therapeutic domains (respiratory; internal medicine; neurology; haematology)

-            Phase I through Phase IV protocols

-            In-depth knowledge of ICH-GCP and regulatory requirements

-            Site selection, budget calculation, negotiation and control

-            Leading local and global studies

-            Study logistics: ordering of study medication & supplies; set-up of laboratories & sample flow

-            Training of Clinical Research Associates on study protocols

-            Study delivery, according to the highest compliance standards and focussed on customers’ expectations and timelines

General competencies

-            Customer focused, analytical approach, negotiation skills, flexible and solution oriented, motivation and supportive skills

-            Good presentation skills

Languages & computer skills

-            Fluent knowledge of Dutch, French and English; basic knowledge of German

-            Set-up of conference calls using BT conferencing, WebEx or Live Meeting Service

-            Computer skills: Microsoft Windows, Word, Excel, PowerPoint, Outlook, MS Project

Professional experience (summary)

 

-            Clinical Program Manager                                               Ablynx NV             2012 - Sep 2014 (end of contract)

Haematology: caplacizumab in Thrombotic Thrombocytopenic Purpura (phase I & II)

-            Clinical Development Manager                                       GSK Corporate                                  2009 - 2011

            Respiratory & Immuno-Inflammation (early phases)

-            Manager Clinical Projects                                                GSK Belgium                                     2000 - 2009

                Respiratory, Osteoporosis, Neurology & Urology (phase I through IV)

-            International Project Manager                                         Medisearch Int.                                   1997 - 2000

-            Clinical Research Associate                                            Clintrials & UCB Pharma                   1992 - 1996

 

Personality

BrightOwl Assessment :
Anger commandKindnessWillingness to compromiseAuthenticityAdaptabilityCreative thinkingInterest in knowledgeCuriosityApproachabilityReaction to stressOrganization

Knowledge

BrightOwl Assessment :
HematologyDiabetesBiotechnologyNeurologyUrologyInternal medicineRespiratoryPhases of clinical development (phase I to IV)Good Clinical Practice (GCP)Good Clinical Practice (GCP)Clinical researchProtocol

Skills and Expertise

BrightOwl Assessment :
Coach and provide guidance to clinical staff.Ensure consistency between the protocol and CRFPlan work to meet objectives and deadlines Write protocolsCalculate timelines for conducting and completing the trialDevelop ICH/GCP compliant processesInteract with physiciansAct as the main line of communication between the sponsor and the investigatorIdentify and provide training to trial team and associated staffTrain off site staff to trial specific and industry standards.collaborate in research projects at universitiesCreate clinical project documents according to the protocolConduct literature searches.develop the study budget
Self Assessment :
Act as the main line of communication between the sponsor and the investigatorApprove 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.Attend at steering committee meetingsattend Investigator meetings requiring travel and report pertinent information back to research team members.Calculate timelines for conducting and completing the trialCoach and provide guidance to clinical staff.Attend seminars, courses and meetings within and outside the companycollaborate in research projects at universitiesCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collect data as required by the protocol and complete case report forms and reviews for completeness.control different protocol versions and other essential documentsConduct literature searches.Coordinate with the ethics committeeCoordinate approval of new study agreements and contracts.Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials Design, document, test, implement and manage clinical data collection and reporting systemsDetermine availability of facilities and equipment at the siteCreate clinical project documents according to the protocolDirect co-workers to achieve resultdevelop and manage comprehensive study timelines and metrics;develop the study budgetEnsure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPsEnsure consistency between the protocol and CRFEnsure that all meetings arranged run smoothly by producing agenda, including timetable, minutes and action pointsIdentify and provide training to trial team and associated staffInteract with physiciansInteract with pre-clinical scientistsLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredLiaise with research team in order to accurately collect and record datamanage study budget and maintain it within financial goalsObtain grants for clinical researchPlan work to meet objectives and deadlinesPrepare required regulatory documentsprepare study-related documentation; Provide financial reports to the senior managementReview and approve monitoring reports, track ongoing issues and query resolutiontake responsibility for completing all study specific procedures according to the study protocol.Train off site staff to trial specific and industry standards.Work collaboratively with the other members of the clinical research team Work with coordination and data management teamsWork with the PI to manage the day-to-day activities of the study including problem solving and protocol management.

Education

  • 0 in Pharmacy from University of Ghent in 2014
  • 0 in Pharmacist from RUG in 2014

Work Preferences

  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer :    40 Hours per week
  • International:
    No

Area / Region

Keerbergen

Others

Driving License
  • Yes