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Associate Site Manager with Italian and English language

Aplica ya
Mapa de ubicación: Sofia, Bulgaria Full time R1263448

Descripción del trabajo

RESPONSIBILITIES

  • Complete appropriate therapeutic, protocol and clinical research training to perform job duties.

  • Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites.

  • Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.

  • Under close supervision, may perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs and work instructions.

  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

  • Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.

  • Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.

  • Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.

  • Gain experience with standard IQVIA tools, metrics and reports.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s Degreein Life Science, Health science or Pharmacy, is a must

  • Excellent written and verbal skills in English and Italian language (C1 minimum)

  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.

  • Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is preferred.

  • Basic organizational, interpersonal and problem-solving skills

  • Strong attention to detail

  • Working time management skills

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites

PHYSICAL REQUIREMENTS

  • May require occasional travel

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Aplica ya

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