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, Istanbul, Turkey
Job reference: R-050838
Posted date: May. 14, 2019

Background & Qualifications ​​

  • University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
  • Advanced level of English,
  • Minimum 5 year experiences in Clinical Research (preferably 2 years in Project Management positions),
  • Project management skills,
  • Strong communication and negotiation skills,
  • Ability to prioritize and handle multiple tasks,
  • Basic coaching skills and good at team work,
  • Financial management skills,
  • Effective planning and organizational skills with result-oriented approach,
  • Stakeholder management experience,
  • Analytical thinking, critical reasoning ability,
  • Good command of MS Office applications,
  • No restriction to travel,
  • Driving License,
  • No military obligation for male candidates.

Summary Job Description ​

  • Leading the local study teams (consisting of monitors and study administrators) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines
  • Ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived
  • Ensuring timely submissions of proper application/documents to Ethic Committee/Regulatory Authority.
  • Close communication with global study teams and overall responsibility for study commitments, for timely delivery of data to required quality as agreed with global
  • Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patience admission processes in coordination with the researchers; planning and taking the necessary precaution when required
  • Ensuring the compliance of the clinical research process with ICH-GCP practices, the study protocol, AZ Global and Local Clinical SOP’s, and the Ministry of Health Clinical Research Regulations; being knowledgeable about these procedures and keeping abreast of any changes and revision
  • Participating in system/process improvement projects within global and local task groups consisting of employees from different units

Local Study Manager SMM
Clinical Development

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