After a break of 1 year I’m looking for a new opportunity within clinical research and hope to find the right job.
I have a broad experience as project coordinator assisting project managers in EU and USA in large global/multinational studies (Phase II, III and IV). I worked as a project manager for a pharmacy monitoring study in several countries. And I’m also very experienced as a clinical trial assistant on many studies in Belgium.
“I feel that my greatest strengths are my strong organizational skills: planning and coordinating, this to work efficiently on a project and to give the best possible service to team members and customer. Secondly my skill of being an excellent administrative support on different levels supported with a very good knowledge of several computer software (Ms office, sharepoint, … ) . Thirdly my desire to do everything possible to ensure that any project I work for not only meets but indeed exceeds all of the goals and targets set for it.”
My major accomplishments at prior companies include:
Completion of a final archive of the entire TMF for a study. This TMF consists paper and electronic records. All documents were collected, a complete file check was done and TMF was compiled in paper files and electronic version as per study procedures and shipped to sponsor within agreed timelines.
Leading and coordinating the investigator payments on a large global study, containing more than 20 countries. There was a high backlog and within agreed timelines, these payments were followed-up and cleaned up for all countries.
Organising IM in Amsterdam, Budapest: making hotel reservations, follow-up on attendee confirmations, set-up agenda and create powerpoint presentations, arranging taxi bookings between airport-hotel,
Acting successfully as CPM for all finances of an RA pharmacy monitoring study: taking care customer contract, change order, investigator payments, review and agree with customer on country timelines …
Interesting fact: Since 2009 I’m running a restaurant together with my partner in my spare time. I’m mainly responsible for general administrative tasks, orders, reservations, but most importantly for all finances and monthly payroll. Occasionally e.g. bank holidays or when full-house I also serve the clients at the bar and in the restaurant. In June 2001 I successfully completed a training course for lifeguard and received the rescuer certification in lifeguard for swimming pools.
Currently I am looking for a suitable position with a company that provides an excellent benefits package, competitive salary and career growth opportunities. I am looking for a 80% employment, with possibility of working home based.
Clinical Project Support Specialist
January 2011 --- January 2014
I provided full support and assistance to project manager and clinical team related to assigned projects. Working in following indications: Internal Medicine and Immunology, Gastroenterology, Rheumatology , Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Osteoarthritis, Osteoporosis, - maintain all project documentation including all files, records and reports according to scope of work and SOPs - conduct periodic review of files for accuracy and completeness - update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information. - Prepare and distribute status, tracking and project finance reports - manage project finances: invoicing, contracts, change orders. - prepare and present project information at internal and external meetings - prepare presentation materials for meetings and project summary data - coordinate project team and/or customer meetings including logistics and materials required - train and mentor junior support staff
October 2007 --- December 2010
Provided full support to Project Manager and Clinical team. Working in following indications: COPD, asthma, Rheumatoid Arthritis, Ulcerative colitis
Clinical Trials Assistant
December 2004 --- September 2007
Administrative support to CRA and follow-up with sites for assigned projects. Update clinical tracking systems, preparing and follow-up of EC and RA submissions, tracking and sending CRF page and queries to DM, investigator contracts and payments Working in following indications: diabetes, Kidney Disease, Anemia, HIV, Influenza, Rheumatoid Arthritis.
Skills and Expertise
Administrative supportAdverse event reportingArchive documentationArchive study documentsClinical data collectionCoach staffCollaborate with project teamCollect financial data from hospitalsCommunicate with investigatorCommunicate with sponsorCollect patient forms and questionnairesComplete case report form (CRF)Complete study proceduresConduct the trialCreate clinical documentsCreate study documentsData entryDevelop study timelinesDistribute study documentsDistribute trial suppliesEnsure good clinical practice (GCP)Ethics committee submissionsFinancial administrationFinancial reportsFollow-up of internal auditsGeneral office managementHandle callsInformed consent processManage study budgetManage study supplyManage trial master file (TMF)Manage vendor budgetsNegotiate budget Negotiate payment schedulesOrganise meetingsRetrieve study documentsWork under specific instructions Build and manage the Trial Master File (TMF) Control data Guide students Interact with nurses Report data
in Bachelor in Office Management, Medical Management Assistant from Katholieke Hogeschool Leuven in 2004