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 firstname.lastname@example.org phone: +31 6 3977 5633 (NL) (Skype upon request)
(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 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.
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.
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
Attention to detailCreative thinkingCritical thinkingInnovative thinkingProblem solvingSelf-disciplineStrivingTrustKindness
(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) Certification