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For our location in Berlin-Schöneberg we are looking as soon as possible for a

Clinical Study Manager (m/f/d)

Your team

You work independently but in an interdisciplinary team closely together with employees from the Quality Management and Research & Development teams. TIB Molbiol develops PCR-based detection assays that are used in diagnostics as well as in research.

Your tasks

  • You develop relevant SOPs for the clinical performance process and performance studies that comply with regulatory requirements.
  • You develop study design and protocols, manage and drive studies as project manager including study financials and study prioritization and manage CROs and/or external partners
  • You support specific business initiatives
  • You are guiding multiple study sites and you serve as a key facilitator between multiple teams to achieve together all defined objectives and to manage complex efforts
  • You ensure studies are managed in accordance with regulatory requirements such as IVDR and are recorded and reported in accordance with protocol, good clinical practices, standard operating procedures


Your profile

  • You have a Bachelor degree in Life Science / Natural Science or something similar
  • You have good knowledge and understanding of rt-PCR detection methods and respective IVDs and infectious diseases would be of advantage
  • You have 2 or more years of experience in the field of clinical research / clinical study management
  • As a well-structured person you drive projects forward
  • You enjoy working in a divers team and a good collaboration is one of your keys to success
  • You are a reliable person with initiative and a solution-oriented attitude and you are able to keep track and prioritize even during busy times
  • You have - ideally - good knowledge and understanding of the most important standards and regulations (ISO 13485, ISO 14971, IVDR, GCP)
  • You have excellent verbal and written communication skills in English and good communication skills in German
  • Biostatistical understanding and willingness to travel would be an advantage


Our offer

  • You will get a permanent position in an internationally successful and growing company
  • You will benefit from the broader Roche network and interact with various interfaces from other Roche locations
  • You will be part of a great team of specialists
  • You benefit from short decision-making processes and a lot of creative freedom


If you feel addressed, then please send us your application with CV and references, stating your salary expectations and the possible starting date by e-mail to: [email protected].

Questions? Feel free to contact me on LinkedIn or by mail: [email protected]

TIB Molbiol GmbH

Melbourne
Australia

T +61 43 811 9487
F
[email protected]

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TIB Molbiol GmbH
Eresburgstraße 22-23
12103 Berlin
Germany

T +49 30 787 994 55
F +49 30 787 994 99
[email protected]

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TIB Molbiol S.r.l.
Largo Rosanna Benzi, no. 10
16132 Genova
Italy

T +39 010 362 8388
F +39 010 362 1938
[email protected]

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TIB Molbiol, LLC
PO Box 190
NJ 07710 Adelphia
USA

T +1 732 252 1110
F +1 732 252 1109
[email protected]

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TIB Molbiol S.A.S.
Carrera 100 # 5-169 Oficina 613 C
Santiago de Cali
Colombia

T +57 234 729 96
F
[email protected]

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TIB Molbiol SL
Calle Isabel Colbrand, 10 Nave 130
28050 Madrid
Spain

T +34 91 344 6642
F +34 91 344 6670
[email protected]

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