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Marcin Stefanowicz, PhD

Marcin Stefanowicz, PhD

General Science Manager

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location of Marcin Stefanowicz, PhDWarsaw, Mazowieckie, Poland

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  • Timeline

  • About me

    Regional Study Manager | Clinical Project Management | Operation and People Leading | Innovation & Technology Ambassador| Clinical Trial Promotor

  • Education

    • Śląska Akademia Medyczna w Katowicach

      2007 - 2013
      Doctor of Philosophy (PhD) Biological medicine

      Activities and Societies: Ph.D. at Silesian School of Medicine Key words: Imaging in clinical trials. Radiology, Radiobiology, Clinical Trials, Computed Tomography, Ionizing wave, Imaging.

    • EduGRANT - with project to new technology. Organized by Heart Foundation Disease

      2013 - 2014
      Certificate Human Capital Programme (EU project) N/A

      Activities and Societies: Managing project and research project in science English course for research with TOEFL certificate On 28 September 2007, the European Commission took the decision to implement the Operational Programme Human Capital. It is one of the programmes devised to implement the National Strategic Reference Framework (NSRF) 2007-2013 and it covers the entire intervention of the European Social Fund (ESF) in Poland. The approval of the Programme confirms development of the main directions of the governmental employment policy and it enables the efficient use of the ESF funds by Poland within the period… Show more On 28 September 2007, the European Commission took the decision to implement the Operational Programme Human Capital. It is one of the programmes devised to implement the National Strategic Reference Framework (NSRF) 2007-2013 and it covers the entire intervention of the European Social Fund (ESF) in Poland. The approval of the Programme confirms development of the main directions of the governmental employment policy and it enables the efficient use of the ESF funds by Poland within the period 2007-2013. Show less

    • Astra Nova

      2012 - 2012
      External training (course) Clinical Trials

      Activities and Societies: Build a Career as a Clinical Research Investigator - FDA and EMA Regulations. 1 day course, certified.

    • Viena School of Clinical Research

      2011 - 2011
      Course Applying Good Clinical Practice

      Activities and Societies: Pitfalls and Challenges of GCP Implementation in Clinical Trials. Successfully passed the final exam. Course accredited by the European Accreditation Council for Continuing Medical Education (EACCME). 11 European CME credits (ECMEC's).

    • Viena School of Clinical Research

      2010 - 2010
      Course and sucessfuly passed exam Project Management in Clinical Research

      Activities and Societies: Successfully passed the exam. VSCR has been accredited by the European Accreditation Council for Contiunuing Medical Education (EACCME) to provide the following CME activity for medical specialists.

    • Jagiellonian University

      2014 - 2014
      External 5-day course (see course section) Practical aspects of designing, analysing and conducting clinical trials. Certificate

      Activities and Societies: Jagiellonian University with collaboration with European Union Funds delivered 5-day course leads and act by lecturer Prof. Thomas R. Fleming, PhD. Proessor, Dept. of Biostaticts University of Washington.

    • Uniwersytet Śląski w Katowicach

      2001 - 2004
      B.Sc. Physical medicine

      Activities and Societies: Physic Student Association Experiences / Laboratory Practise:1. Cardiosuregry: Evidence and test physical model and surgery instruments in minimally invasive cardiosurgery with use surgery robot. Foundation Development Cardiosurgery, Silesiam School of Medicine.2. Practical work in the Silesian Center Heart Diseases of Silesian University School of Medicine.3. Diagnostic Imaging - CT and MRI, Practical work in the Central Clinical Hospital (Department of Anesthesiology, Surgery, Neurology, Pulmonology) and… Show more Experiences / Laboratory Practise:1. Cardiosuregry: Evidence and test physical model and surgery instruments in minimally invasive cardiosurgery with use surgery robot. Foundation Development Cardiosurgery, Silesiam School of Medicine.2. Practical work in the Silesian Center Heart Diseases of Silesian University School of Medicine.3. Diagnostic Imaging - CT and MRI, Practical work in the Central Clinical Hospital (Department of Anesthesiology, Surgery, Neurology, Pulmonology) and Helimed - Silesian Center Diagnostic Imaging in Katowice Show less

    • Jagiellonian University

      2008 - 2009
      Post-graduate Industrial Pharmacy

      Activities and Societies: Collegium Medicum, Pharmacy Department.

    • Jagiellonian University

      2014 - 2014
      External course Clinical trials

      5-day external course conducted by Jagiellonian University, Collegium Medicum. Topic "Practise aspects of projecting, monitoring and analysing randomized clinical trials results". Lecturer: prof. Thomas R. Fleming from Washington University (Seattle).Date: 24-28 Feb-2014.Certificate delivered.Discussed topics:1. Types/phases of studies, protocol/target population/MOP, Bias/Variability: MIssing Data, Sample Size2. Biomarkers and Surrogate Endpoints in Clinical… Show more 5-day external course conducted by Jagiellonian University, Collegium Medicum. Topic "Practise aspects of projecting, monitoring and analysing randomized clinical trials results". Lecturer: prof. Thomas R. Fleming from Washington University (Seattle).Date: 24-28 Feb-2014.Certificate delivered.Discussed topics:1. Types/phases of studies, protocol/target population/MOP, Bias/Variability: MIssing Data, Sample Size2. Biomarkers and Surrogate Endpoints in Clinical Trials.3. Addressing Missing Data in Clinical Trials4. Monitoring Guidelines5. Exploratory Analyses: Why Do we Need Particular Caution? Show less

    • Uppsala University

      2000 - 2001
      Course International Course

      Activities and Societies: International courses in the Baltic University i.e. Silesian University in Katowice and Uppsala Univeristy in Uppsala.

    • University of Silesia in Katowice

      1996 - 2002
      M.Sc. General Biology

    • Jagiellonian University

      2012 - 2012
      External course GCP for Investigators Certificate-dyploma

      Activities and Societies: One-day session established by Jagiellonian University with cooperation with lecturers from Clinic Hospital and Polisih Association Good Clinical Practice.

    • Stanford University

      2018 - 2018
      Course Introduction to Artificial Intelligence

    • Jagiellonian University

      2003 - 2004
      Post-graduate Molecular biology

      Activities and Societies: Post-graduate study at molecular biology, industrial pharmacy. I was a student at two post-graduated studies.

  • Experience

    • Dental Medical Clinic Silesia-Med

      Jan 2004 - Apr 2006
      General Science Manager

      1. Works with science team2. Prepare science projects in dental3. Monitors laboratory trials3. Manages scientific staff

    • Pharmaceutical Research Associates

      May 2006 - Apr 2014

      Achieves successful delivery of clinical activities by meeting internal and external client requirements. Oversees the management of investigator sites to ensure compliance with the protocol, contract, ICH-GCP and applicable regulations and SOPs.Project Oversight and Leadership: leads and manages the clinical team; works with the PM to facilitate cross functional team and sponsor communication; oversees start-up activities; provides performance/project status metrics; identify issues and risks to clinical activities and develops contingency/plans; reviews filing of Essential Documents in the electronic TMF.Project Resourcing: takes active part in clinical resource request process; liaises with Clinical Operations Managers to resolve resource and performance issues; effectively manages clinical monitoring resources throughout the study; oversees transition plans.Training and Development: creates clinical project documents; plans, oversees, and conducts study specific training for the team; responsible for site monitoring activties (tracking an resolution of issues, review and approval of reports, co-monitoring visits, tools preparation).International clinical trials experience in:Neurology - pediatric population, phase II Rheumatology - arthritis indications, global international project phase IIIHematology (backup CTM) - phase II, III, global international project Show less Monitors the progress of clinical studies at investigative sites, and ensures that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.Therapeutic experience:• Atrial Arrhythmia (trials: 1, phases: II) 1 mon• Hyperlipidemia (trials: 1, phases: III) 3 mon• Hypertension (trials: 1, phases: IV) 8 mon• Unstable Angina (trials: 4, phases: II,IV) 4 yr• Hematology: Acute Myeloid/Myelogenous-AML (trials: 2, phases:• II,III) 1 yr, 11 mon• Immunology: Ankylosing Spondylitis (trials: 1, phases: III) 1 mon• Psoriatic Arthropathy (trials: 1, phases: III) 2 mon• Ulcerative Colitis (trials: 1, phases: III) 1 yr, 2 mon• Neurology: Chronic Pain (trials: 2, phases: III) 1 yr, 7 mon• Epilepsy (trials: 5, phases: II,III) 10 yr, 5 mon• MS (trials: 3, phases: I,III,IIIB) 2 yr, 4 mon• Parkinson's Dementia (trials: 1, phases: III) 8 mon• Parkinson's Disease (trials: 1, phases: III) 1 yr, 8 mon• Oncology: NSCLC (trials: 3, phases: I/II,II,III) 5 yr, 5 mon• Ovarian (trials: 2, phases: I/II,III) 5 yr, 6 mon• Renal Cell Carcinoma (trials: 2, phases: IIB,III) 4 mon• Psychiatry: ADD/ADHD (trials: 2, phases: III) 9 mon• Respiratory: Mild/Mod Asthma (trials: 1, phases: II) 11 mon• Seasonal Rhinitis (trials: 1, phases: III) 3 mon• Rheumatology: Arthritis (trials: 1, phase: III) 1 yr• Other Relevant Experience:• CABG (Student teacher) 2 yr• Dentistry: Dentistry Indications (Scientific Manager) 2 yr• Radiology: Pathologies (Student teacher) 2 yr Show less

      • Clinical Team Manager

        Nov 2011 - Apr 2014

      • Senior Clinical Research Associates

        Nov 2009 - Nov 2011

      • CRA II

        Nov 2007 - Nov 2009

      • CRA I

        May 2006 - Nov 2007

    • Jagiellonian University, Collegium Medicum, Pharmacy Department

      Oct 2011 - Dec 2013
      Lecturer in Clinical Trial post-graduate study

      Postgraduate studies in clinical trials of medicinal products offer participants the opportunity to become fully familiar with the problems of clinical research, from planning the study, by his conduct in the process of completing the assessment results. The purpose of this course is to acquaint students with the ethical, legal and organizational aspects of the planning and conduct of the trial and to present the tasks and the role of governmental and non governmental organizations supervising the safety of patients taking part in clinical trials.See more (in Polish): http://farmacja.cm-uj.krakow.pl/index.php/studia_podyplomowe/Page;podypl_badamia_kliniczne Show less

    • ClinAcademy

      Jan 2016 - Jan 2016
      Trainer/Provider

    • Roche

      Jun 2016 - now

      I am Study Manager responsible for EMAI region, i.e. Central and Eastern Region of Europe included South Africa in old model. Oversee the free main areas of project managing included and not limited to financial aspects: contracts with sites in all participating countries, payments for Investigators and managing finance at clinical operation level as well. People managing in terms of cooperation on clinical operation level across all participated countries, close contacts with monitors, stakeholders and groups responsible for designated tasks in the project: as regulatory submission for instance.Deep feasibility process, beginning at Kick-Off Meeting, throughout internal meeting and Investigator meeting, but of course with activities related to sites selection first. Set up commitment for region on the reasonable level based on data analyzed on full data and inputs. Show less

      • Regional Study Manager, Central and Eastern Europe

        Jun 2014 - now

      • Ambasador and Member of Innovation & Technology Group

        Jun 2016 - now

  • Licenses & Certifications

    • • 4th Workshop in Measures in Acute Coronary Disorders

    • 2nd Symposium of Silesia Med European Union as the challenge for Polish Dentistry

    • Clinical Trial Monitoring and CRA job

      Medical Training Organization

    • Inspection as quality-control tool of clinical trial.

      Polska Izba Przemsyłu Farmaceutycznego i Wyrobów Medycznych POLFARMED. Voluntary and self-governing organization POLFARMED.

    • Membership Certificate of Polish Implantology Association

    • Polish Association of Cardio-Thorax Surgery Congress

    • • Certificate of participation in the course called “Patient’s radiology prevention in radiology”

      Nov 2008

    • • Certificate of participate in the Minimal Invasive Cardiosurgery Conference

      PTK
      May 2005

    • Certificate of participate in the Cardiosurgery Conference, Silesian Center of Heart Disease, 12th International Cardiology Conference and 6th Invasive Cardiology Workshops

      Silesian Center of Heart Disease
      May 2005

    • Certificate of participation in the Conference: Dental medical in EU

      Silesia-Med
      Apr 2005