Clinical Submission and Contracts Officer /Code: CSCO - HeaDS
Τετάρτη 11 Ιούλ 2018
Health Data Specialists (HeaDS), an Athens, Greece based CRO with a global reach, is seeking a qualified professional to coordinate the international clinical regulatory operations in Europe and Middle East.

Based in Athens, the successful candidate’s primary focus will be to lead submission process in different countries, including Greece. He or She will have an understanding of the research environment and a commitment to high standards of operational excellence.

Main responsibilities:
The Clinical Submission and Contracts Officer will:

  • Perform local clinical trial applications in Greece with follow through to ensure successful outcome.
  • Co-ordinate in collaboration with cross-functional teams clinical trial applications in various countries.
  • Set-up and review of clinical trial agreements, confidentiality agreements, letters of intent etc. to ensure timely clinical trial start and compliance to the applicable local legislation.
  • Provide support for activities with outside vendors and business partners, as required (such as service agreements and work orders review).
  • Ensure that regulatory documentation and contracts are compliant to legal, regulatory regulations and company SOPs.
  • Facilitate proper filing of relevant documentation.
  • Ensure proper tracking of start up activities in Company’s n project management tools.
  •  Track changes/amendments to legislative acts pertaining to clinical trials in Greece and timely notification of all parties involved; liaise with other local teams to collate the relevant regulatory framework.
  • Assist in relevant SOPs and guidelines’ writing, maintenance.

Job Requirements Qualifications:

  • At least 2 years’ experience in managing regulatory aspects of clinical studies; good knowledge of Greek regulatory environment.
  • University degree in Life Sciences or Pharmacy is preferred.
  • Excellent command of English, both oral and written.
  • Excellent communication, planning and organizational skills.
  • Demonstrated ability to multi-task and work effectively in a fast-paced environment.
  • Proficiency in standard MS Office applications.

Join us to be part of a multidisciplinary team of highly skilled professionals in the forefront of Clinical Research within a friendly work environment. Competitive remuneration package comes on top.

Please submit your application via email to info@heads.gr indicating the position code.
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