Mariusz Olejniczak

Current

General Manager of Assign Clinical Research Poland Sp. z. o. o. at Assign Clinical Research Poland Sp. z o.o.

Past

contract CRA at SKM Clinical Research GmbH /Assign Clinical Research GmbH / CEMA
Marketing Manager at G.C.Z.M. Zarys Sp. z o.o.
Biologist at Foundation of Development in Cardiac Surgery/NZOZ FRK Homograft

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Education

Akademia Ekonomiczna im. Karola Adamieckiego w Katowicach
Politechnika Slaska w Gliwicach
Akademia Rolnicza im. Augusta Cieszkowskiego w Poznaniu

2nd Annual CEE Clinical Trials Conference
Konferencja: "Badania Kliniczne - nowe Prawo Farmaceutyczne i Prawo badań Klinicznych" 2008 Poland
Trainings by CRDE, Polfarmed, GCPPL, SKC, Assign and many others.

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Recommended

2 people have recommended Mariusz

Connections

310 connections

Industry

Pharmaceuticals

Websites

Mariusz Olejniczak’s Summary

Mariusz Olejniczak is General Manager and co-owner of Assign Clinical Research Sp. z o.o. Assign Clinical Research Sp. z o.o. is a company registered in Poland and member of Assign Group. Assign Group provides services in pharmaceutical research from offices in Austria, Germany, Hungary and Poland. Assign Data Management and Biostatistics GmbH, Assign International GmbH, Assign Hungary Klinikai Kutatás Kft. and Assign Clinical Research Poland sp. z.o.o are members of Assign Group, a clinical research organization, the members of which are separate and distinct legal entities. For further information, please refer to www.assigngroup.com.

Assign Group provide both in insourcing and outsourcing services including:
Feasiblity/Prefeasiblity in Poland and CEE/EU,
Clinical trials consulting (e.g. SOPs, reports, literature reviews)
Protocol writing and statistical design
Data Management Plan
CRF development: pCRF and eCRF (InterTrial)
Submissions to ECs and CAs
Study management and monitoring
Coding (MedDRA, WHO-DRL, ATC)
Pharmacovigilance, safety desk
Study reports and statistical analysis
Report writing

Assign Clincial Research Sp z o. o.
Biuro Firmy
ul. Zwyciestwa 10 pok. 401
44-100 Gliwice
Poland

mobile +48605436167
phone +48 32 332 54 72
fax +48 32 231 13 44
www.assigngroup.com

Mariusz Olejniczak’s Specialties:

Knowledge of Polish/EU regulations for clinical trials.
Feasiblity/Prefeasiblity in Poland and CEE/EU.
Observational (non-interventional studies).

Mariusz Olejniczak’s Experience

General Manager of Assign Clinical Research Poland Sp. z. o. o.

Assign Clinical Research Poland Sp. z o.o.

(Privately Held; Pharmaceuticals industry)

March 2006 — Present (3 years 5 months)

•Manage staff to ensure completion of projects on time
•Foster excellent relationships with sponsors and act as the representative of Assign Group
•Manage all business relationships of Assign Clinical research GmbH with sponsors and communicate effectively with sponsors, investigators, sub-contractors and partners of Assign Group
•Act as mentor for Project Managers
•Supervising of project teams and/or sub-contractors within Assign
•Provide leadership to all members in the delivery of services to clients; review of work produced by the project teams and sub-contractors
•Ensures that teams fulfil their responsibilities in accordance with the sponsor and Assign´s policies, procedures and SOPs
•Day-to-day management of all Assign activities in order to make sure that projects are delivered according to the client expectations, time schedules and budget
•Represent Assign on conferences and meetings
•Human resource management, cooperate with internal and external QA, support
contract CRA

SKM Clinical Research GmbH /Assign Clinical Research GmbH / CEMA

(Pharmaceuticals industry)

2003 — 2006 (3 years)

•Performs clinical monitoring tasks
•Serves as primary contact person to relevant investigators
•Interacts with client and participates in client meetings
•For all assigned projects, reviews protocols, CRFs, and other relevant study documents and interacts with his/her functional leader and project team to develop a thorough and unambiguous understanding of all tasks required as well as schedules of project timelines and priorities
•Contributes to Assign`s continuous improvement efforts
•Helps establishing client approved CRF monitoring guidelines, if appropriate; consults on CRF design
•Participates in investigators meetings
•With regard to study coordination activities, maintains documentation of study related issues, enrolment status and expenses for billing activities
•Interacts with project manager and other functional group members to ensure timely resolution of project issues
•Assume role of project manager
Marketing Manager

G.C.Z.M. Zarys Sp. z o.o.

(Privately Held; 51-200 employees; Medical Devices industry)

2000 — 2004 (4 years)

The firm is an important distributor of polish and imported medical devices and in vitro devices manufactured in Poland and aboard. Zarys Sp. z o.o. is working with 1300 health care organizations and have 12 sales persons (sales representative and product manager) trough all Poland.
Responsibilities: contact with customers, vendors and Polish authorities (including Office of Registration), acquisition new lines of business implementation of new products, assuring compliance with EU. directives for medical devices MD and in vitro devices (IVD), supervising sales persons.
Biologist

Foundation of Development in Cardiac Surgery/NZOZ FRK Homograft

(Non-Profit; 11-50 employees; Biotechnology industry)

1998 — 2000 (2 years)

Work in tissue bank: preparing and examining biological implants and equipment. I was in charge of many scientific and business programs and activates (also clinical trials) and for part of QC.

Mariusz Olejniczak’s Education

Akademia Ekonomiczna im. Karola Adamieckiego w Katowicach

Post-MSc. studies Foreign Trade 2001 — 2002

End theme ”Attestation of medical materials due to harmonization of Polish and EU. regulations.”
Politechnika Slaska w Gliwicach

Post-MSc. studies Quality Management. 1999 — 2000

End theme “Using SWOT analyses for choosing the best way of certification for tissue bank
Akademia Rolnicza im. Augusta Cieszkowskiego w Poznaniu

MSC , 1993 — 1998
2nd Annual CEE Clinical Trials Conference
Konferencja: "Badania Kliniczne - nowe Prawo Farmaceutyczne i Prawo badań Klinicznych" 2008 Poland

Konferencja: "Badania Kliniczne - nowe Prawo Farmaceutyczne i Prawo badań Klinicznych" 2008
Trainings by CRDE, Polfarmed, GCPPL, SKC, Assign and many others.

GCP/ EU & Polish regulations

Additional Information

Mariusz Olejniczak’s Websites:

Mariusz Olejniczak’s Interests:

Clinical trials and powerkiting.

Mariusz Olejniczak’s Groups:

The Association for Good Clinical Practice in Poland,

Medical Device Networkers
QualityNet - Quality Professionals Network
Lifesciences Opportunities in US
Pharmaceutical Discussion Group
Good Clinical Practice
Poland
CLINICAL GLOBE
Regulatory Affairs Info Exchange
Clinical Project Managers Network (Europe)
Regulatory Affairs Professionals
Biotech & Pharma Professionals Network
Professionals in Pharmaceutical Industry and Biotech Industry
Life Sciences Outsourcing
BIO - ALLIANCE
CRA Network
The Life Science Executive Exchange
Clinical Development and Operations Info. Exchange
Licensing professionals in life science industry
SERVICES FOR PHARMA
Partnerships with CROs
Medical Device Professionals Network
CRO and CMO, CRAMS (Contract Research/Development/Manufacturing Organizations) Professionals
Clinical Trial Performance Spot
Polish Pharma Market
Worldwide Medical Device professionals Network
Contract Research/Manufacturing Organizations (CROs & CMOs)
CRA LOUNGE™
Pharma Trials
CEE Clinical Trials Partnership
Outsourcing in the Central and Eastern Europe
Seeking Clinical Answers
Life Sciences Opportunities in EU
Clinical Research Opportunities in Poland
CEE R&D Pharma & Medical Devices Network
SEC's Pharmaceutical Discussion
Oncology Pharma
4th Annual Clinical Site Partnerships in CEE