Site Manager *** TURKEY *** Home based / office based

Site Manager *** TURKEY *** Home based / office based

Job title: Site Manager *** TURKEY *** Home based / office based

Company: DOCS Global

Job description: Description:

  • Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
  • * Acts as primary local company contact for assigned sites for specific trials.
  • * Attends/participates in investigator meetings as needed.
  • * Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
  • * Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
  • * Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
  • * Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
  • * Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).

Profile:

  • * A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
  • * Must have experience in Clinical Research or equivalent qualification
  • * Usually 0-2 years’ experience monitoring on site
  • * Specific therapeutic area experience may be required depending on the position.
  • * Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
  • * Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
  • * Proficient in speaking and writing the country language and English.
  • * Good written and oral communication skills.

Expected salary:

Location: Türkiye

Job date: Wed, 16 Jun 2021 22:11:25 GMT

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