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Summary

eu based pmp, experienced Clinical Trial imaging (corelab) manager (CRO/biotech/pharma/medical Software) Freelance, permanent & other propositions welcome (also expat, e.g. asia, uae).

assignments: imaging CRO support / Project Management / consultancy / Trainer / corelab Documentation writing / virtual team management / med. image qc / qa

20+ years experience in Clinical trials-med. imaging, last 12+ years as Project Manager at global imaging cros, specialized in image management & review. - eu located, but also supporting usa, middle east & asia. - close connection with asia i succesfully lead approx. 30 Phase 2/3 trials for therapies as below, some with novel imaging methodologies. contract values 75k - 20 m. my added value, a niche skill-set combination: hands-on radiologic imaging experience (in Hospitals nl + middle east ), later followed by innovative Clinical Trial imaging management positions.

 

former co-workers will say that i am a precise, dedicated, analytical, creative, innovative, Problem Solving and decision making pmp. a client retainer and generator of new bd opportunities. i contributed with recognized commitment and creativity significantly to the growth of a globally operating icro. played an active role, turned challenges into process improvements, helped the icro to become mid-size and a top quality performer.

interested in matching-roles, limited-hour-assignments are also welcome: Medical Imaging CRO / biotech / Clinical Trial imaging Start-ups / imaging sw & hw. Therapeutic Areas- trial experience: CNS / oncology / ra / msk / spine / cartilage / cardio-Vascular / orthopaedic devices

imaging modalities experience: MRI / ct / x-ray / diagn. & interv. angio / mammography / dxa / pet

web: http://members.ziggo.nl/clintrimag/clintrimag/home.HTML i welcome inquiries and connection requests at achterberg.pieter@gmail.com phone: +31 6 3977 5633 (nl) (skype upon request)

Experiences

Current Experience

  • (Freelance) Clinical Trial Imaging (Corelab) Project Manager / Consultant


    Since January 2013

    currently supporting imaging corelabs / biotech : independent, eu-home-office based, but also working experience usa / middle east / asia. hours available for new clients ! immediate start ! (short & long term propositions welcome)

    i give support for: • entrepreneurs starting a med. imaging co. / icro • full service cros without imaging division • setting up Medical Imaging (e.g safety MRI) in alzheimer's trials. • med. image quality reviews (qc / qa) • transition of small scale kol -publication set-ups into a Phase 2/3 multi center scan science)" rel="nofollow">Protocol. • Investigator meetings, CRA Training, imaging site visits • (Interim) management of a (global) radiology/ readers / imaging team. • Medical Imaging Software evaluation (uat) other examples of services in support of CRO / biotech/device/pharma: ➢ Project Management services, permanently or temporarily ➢ eu/asia timezone support for usa/asia-based icros ➢ support with selection of imaging CRO for trials ➢ delivering a quote for the trial's radiological imaging part ➢ imaging proposal review (for completeness / deliverables) ➢ assistance with operational aspects of proposals/contracts ➢ bd related tasks at congresses ➢ vendor oversight, managing external icro deliverables ➢ help with set-up of image transfer techn. + Communication module ➢ Project Management support of imaging deliverables for Clinical trials in less common Clinical Trial countries, e.g. asia / eastern eu / middle east region. ➢ contribution to Clinical Trial imaging docs /requirements: imaging charter (irc), imaging Logistics, image identification management, image Quality Control, review methodologies, image spec. work instructions and sops.

    see contact section, also see the web: http://members.ziggo.nl/clintrimag/clintrimag/home.HTML collaborating with herakles Life Sciences group (www.heraklespharma.nl) fyi: the herakles Life Sciences group is not an imaging CRO, but delivers Clinical Trial staff and supports various CRO services.

    Currently supporting Imaging Corelabs / Biotech : Independent, EU-home-office based, but also working experience USA / Middle East / Asia. Hours available for new Clients ! Immediate start ! (Short & long term propositions welcome)

    I give support for: • Entrepreneurs starting a Med. Imaging Co. / iCRO • Full service CROs without Imaging Division • Setting up Medical Imaging (e.g Safety MRI) in Alzheimer's trials. • Med. Image Quality reviews (QC / QA) • Transition of small scale KOL -publication set-ups into a Phase 2/3 Multi Center scan protocol. • Investigator Meetings, CRA training, Imaging Site Visits • (Interim) Management of a (global) Radiology/ Readers / Imaging Team. • Medical Imaging software evaluation (UAT) Other Examples of Services in support of CRO / Biotech/Device/Pharma: ➢ Project Management services, permanently or temporarily ➢ EU/Asia Timezone support for USA/Asia-based iCROs ➢ Support with selection of IMAGING CRO for Trials ➢ Delivering a quote for the trial's Radiological Imaging part ➢ Imaging Proposal review (for completeness / deliverables) ➢ Assistance with operational aspects of Proposals/Contracts ➢ BD related tasks at congresses ➢ Vendor Oversight, managing external iCRO deliverables ➢ Help with set-up of Image Transfer Techn. + Communication module ➢ Project Management support of Imaging deliverables for clinical trials in less common clinical trial Countries, e.g. Asia / Eastern EU / Middle East region. ➢ Contribution to Clinical Trial Imaging docs /requirements: Imaging Charter (IRC), Imaging Logistics, Image Identification management, Image quality control, Review methodologies, Image Spec. Work Instructions and SOPs.

    See contact section, also see the web: http://members.ziggo.nl/clintrimag/ClinTrimag/Home.html Collaborating with Herakles Life Sciences Group (www.heraklespharma.nl) FYI: The Herakles Life Sciences group is not an Imaging CRO, but delivers Clinical Trial staff and supports various CRO services.

Past Experience

  • Senior Project Manager (PM)

    July 2008 --- January 2013
    senior Project Manager for Clinical trials conducted worldwide at 300+ sites/Hospitals, including asian countries (e.g. china, japan, thailand) for the below listed diseases/Therapeutic Areas. primarily responsible for the Medical Imaging (MRI quality + review processes) of global Clinical trials (investigational Medicine), incl. japan-dedicated studies. mostly amyloid plaque targeting compounds (alzheimer's), but also other indications. in this role i successfully mixed Innovation and new ideas into challenging projects, some of these set-ups were for clients reason to offer more business, explore further collaboration. my past hands-on experience in Medical Imaging helps me to connect to key opinion leaders, Hospital staff and facilitates pharma / CRO clients with regard to the management of demanding image technical requirements for Clinical trials. i am actively involved in proof of concept (poc / pop) situations, other innovative combinations of drug Research and Biomarkers. one of my key responsibilities is the set-up and management of rather uncommon radiologic phenomena while reading scans for Adverse Events. trials/projects: - Neuroscience / CNS (extensive experience in alzheimer’s d., ms, glio blastoma, stroke) - alzheimer’s Vaccines: passive and active immunotherapy targeting aβ in the brain, including monitoring of safety aspects like vasogenic edema (aria-e and aria-h). - rheumatoid arthritis (sharp/van der heijde score) - biologicals: i.v. / s.c application methods - oncology (recist 1 and 1.1) - Vascular disease, cardio-Vascular d. (investigational drugs, including Gene therapy) - cardio-Vascular intervention trials/method (stents, contrast agents, grafts) - biotech/bio-device/Orthopedic device - hiv, vaccine and combination therapies - gaucher disease in addition to Project Management also working with bd staff to acquire new studies and accomplishing internal operational or technical improvements.

  • Project Manager

    August 2002 --- July 2008
    - participates as Project Manager in global Clinical trials in ra, oncology, hiv, cardio-Vascular, bone. - managing virtual project teams. - supervises the set-up up of the bio-imaging part of worldwide Pharmaceutical/biotechnical Clinical trials. - represents bio-imaging technologies at client meetings and conferences. - leads discussions between clients and bio-imaging on image data review methodology and/or imaging charter development. - participates in bd related client meetings (“bid defense”) and/or supports bd in reviewing business proposals. - conducts and/or supervises study related Training visits for Hospital staff. - supervises all project and project / image tracking related issues and is discussion Leader at project kick-off meetings with other bio- imaging staff. - supervises and writes project specific documents. - particpates in writing imaging guidelines, methology docs, charters - participates in internal task forces with focus on: regulations issues, (process) improvement issues, new technology options. - starts up and runs technical challenging or explorer projects.

  • Imaging Analysis Technologist

    December 1999 --- August 2002
    this company's current name is bioclinica. (a global imaging CRO) in this position i performed Quality Control of medical images for Clinical trials: MRI / mra / ct/ x-ray and started to get involved in Quality Assurance and Project Management assignments.

  • Radiographer - Medical Imaging Technologist

    January 1993 --- December 1999
    performing radiologic examinations: - MRI (magnetic resonance imaging), mr-angiography - ct, ct-guided biopsy, ct-angiography - x-ray, conventional and digital Diagnostic radiology - diagnostic angiography & interventional angiography (sterile gown and equipment task): pta / stenting / evar / endovascular coiling / pacemaker / aicd (Operating Room support) - endoscopic intervention support (urologic intervention and ercp). - orthopaedic / surgical Fluorescence support at or - icu and emergency radiologic imaging.

  • (Senior) Radiographer - Medical Imaging Technologist

    August 1990 --- January 1993
    performing x-ray / ct examinations, angiography-interventions and Training junior arabic radiographers. further also emergency room and or support.

  • Radiographer - Medical Imaging Technologist

    October 1985 --- August 1992
    performing radiologic examinations at radiology department and at emergency rooms. day/night and weekend shifts. x-ray / ct / mammography

Personality

Self Assessment :
Attention to detailCreative thinkingCritical thinkingInnovative thinkingProblem solvingSelf-disciplineStrivingTrustKindness

Knowledge

LinkedIn Assessment :
Trial Image ManagementClinical trialsMedical ImagingImaging CRO start-upsImaging Vendor OversightRECISToncologyNeuroscienceCartilage TrialsCROPACSClinical researchMedical DevicesPharmaceutical IndustryICH-GCPMedical writingInfectious diseasesNeurologyDigital ImagingCorelabEDCCardiologyClinical Data Management21 CFR Part 11MRIAsiaQuality Assurance (QA)Clinical monitoringFDAVaccinesAlzheimer's diseaseBrain: ARIA -E / ARIA-H / Vasogenic EdemaX-rayAngiographyMusculoskeletalRheumatoid ArthritisComputed Tomography (CT)DICOMMedical Image TransferBiotechnologyLifesciencesPMPDrug Eluting StentsBrain-MicrobleedsMacOSXOut-of-the-Box thinkingOsteoarthritisInterventional Spine

Education

  • (PMP)® certification (Project Management Professional) in PMI’s Project Management Professional (PMP)® credential from PMI in 2013
  • in Post HBO (graduation) Magnetic Resonance Imaging (MRI) certificate from Fontys Hogescholen in 1996
  • in Post HBO graduation - Angiography and Interventions certificate from EMRIN in 1993
  • BSc comparable in HBO level / Radiology college - graduated from Hogeschool van Utrecht in 1988
  • in HLO (Laboratory-college) from Hogeschool van Utrecht in 1983
  • in Highschool HAVO- graduated from Revius Lyceum in 1981

Training and Certification

  • PMP® (Project Management Professional) in 0000 Certification

Area / Region

The Netherlands

Others

Driving License
  • Yes

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