Michał Majewski

Managing study in countries and acting as a primary point of contact for local study teams:
● Regular communication with local study teams (Europe, North America, Latin America)
● Full awareness of study progress in countries including submission status, recruitments status, data cleaning, important issues. Escalation to Clinical Development Manager if necessary
● Coordination of resolution of issues that cannot be resolved by local study team
Owning a specific area or system for a study globally (IWRS and Investigational Product)
Set-up phase:
● Preparation of study protocol, master consent form, and other study documents
● Preparation of specification of systems to be used in the Clinical Study
● Preparing and presenting at international monitors and investigator meetings
After First Site Initiation:
● Tracking and driving recruitment
● Coordination of data cleaning

Therapeutic area experience: respiratory (asthma, COPD)

Establishing the supply chain for individual/groups of studies and ensuring delivery of the end to end supply of materials to meet study needs
● Monitoring the performance of the supply chain and optimizing for higher volume phases of the project, balancing speed, quality and cost with respect to agreed level of risk
● Monitoring the budget for individual study supply activities and materials for the project
● Managing change in demand and supply, resolving issues, escalating to Supply Chain Program Manager when appropriate
● Using simulation tools to design optimized, lean supply chain for individual studies, defining allocation of contingency stock
● Developing options for how the supply requirements of individual and groups of clinical studies can be delivered and proposing to the Supply Chain Team and Clinical Team during the set-up phase.
● Using this information, develop options for how the supply requirements of individual/groups of clinical studies can be delivered and propose to the Supply Chain Team During set-up phase
● Collaborating with CRO partners (clinical and supply CROs) in development of pack design, study design and review of the technical part of outsourcing contract.
● Providing Study Master Labels, Handling Instructions, Study Supply Strategy Document, reviewing Pharmacy Manual and writing IP related parts of the CSP
● Therapeutic area experience: oncology

Managing study in countries and acting as a primary point of contact for local study teams:
● Regular communication with local study teams (both Europe and North America)
● Full awareness of study progress in countries including submission status, recruitments status, data cleaning, important issues. Escalation to Clinical Development Manager if necessary
● Coordination of resolution of issues that cannot be resolved by local study team
Owning a specific area or system for a study globally (IWRS and Investigational Product)
Set-up phase:
● Preparation of study protocol, master consent form, and other study documents
● Preparation of specification of systems to be used in the Clinical Study
● Preparing and presenting at international monitors and investigator meetings
After First Site Initiation:
● Tracking and driving recruitment
● Coordination of data cleaning

Therapeutic area experience: respiratory (asthma)

TA experience: respiratory (COPD), gastroenterology

TA experience: respiratory (COPD, asthma)

- Providing support to Project Leaders and Clinical Operations Leaders
- Acting as Project Specialist in low-complexity projects
- Initiating, set-up and maintaining Management Systems on a regular basis
- Preparing study specific trackers
- Arranging project related training for project team members under the direction of the Project Leader and maintaining project specific trainings overview and records including study specific system training and access for PI, (new) site staff, study team and new study team members (e.g. IVRS, e-CRF)
- Supporting Project Leader and Clinical Operations Leader in set up of a study specific payment procedure
- Preparing draft project plan including all sub plans
(communication plan, central files maintenance plan,SOP listing, etc) for team discussion
- Preparing project documents and status reports for Project Leader
- Maintaining electronic Central Files
- Managing the project resourcing – resource requests
- Providing internal support to Project Manager as a project resource supporting internal systems and systems set-up

- Odpowiedzialność za zgodny z zasadami GCP przebieg projektów badań klinicznych fazy I i biorównoważności
- Kontrola jakości dokumentacji badań przeprowadzanych w ośrodku
- Współtworzenie dokumentacji badania - CRF, SD
- Kontakty z CEBK, KB, przedstawicielami sponsora
- Inne obowiązki związane z nadzorem i projektowaniem badania klinicznego

- Współodpowiedzialność za zgodny z zasadami GCP przebieg projektów klinicznych
- Współtworzenie dokumentacji badania (PIC, CRF, SD, protokoły, raporty) i współpraca z osobami odpowiedzialnymi za dokumentację


Jako Asystent ds. Zapewnienia jakości (od maja 2009 do lipca 2009)
- Prowadzenie kontroli dokumentacji (ICF, CRF, SD, TMF) w zgodzie z SOP ośrodka i Protokołem Badania.
- Aktualizacja, tłumaczenie na język angielski Standardowych Procedur Operacyjnych
- Monitorowanie wdrażania zaleceń poaudytowych
- Wykonywanie prac związanych z wdrożeniem systemu ISO 9001:2008

Umowa o dzieło:

- zbieranie informacji do projektu naukowego
- tworzenie dokumentacji
- kontakty ze współpracownikami z innych ośrodków naukowych i szpitali

-Wykonywanie badań z zakresu hematologii i biochemii
-Rejestracja skierowań, kontakty z oddziałami