Local Study Manager
GSK
Warszawa,Poland
12 d. temu

Your Responsibilities :

The Local Study Manager (LSM) is accountable for within-country execution and delivery of assigned studies across therapy areas to time, budget and quality as defined in the study protocol as well as in local regulations, ICH GCP / IND guidelines, and GSK written standards.

The LSM serves as the operational point-of-contact between the central study team and in-country operational staff, including Clinical Research Associates (CRAs) / Senior Clinical Research Associates (SCRAs) and other in-

country staff aligned to the study.

Your responsibilities :

  • Accountable for within-country execution and delivery of assigned studies to timelines, budget and quality expectations as defined in the study protocol as well as in local regulations, IND / ICH GCP guidelines, and GSK written standards
  • Responsible to provide leadership and drive decisions related to the conduct of a clinical study locally including escalating issues when required
  • Responsible for matrix leadership and project management of country and site-level activities including oversight of site management & monitoring activities within their LOCs
  • Serves as the operational point-of-contact between the central study team and in-country operational staff, including Clinical Research Associates (CRA) / Senior Clinical Research Associates (SCRAs) and other in-
  • country staff aligned to the study

  • Responsible to identify and sharing best practices, standardizing across the LOC / region and may be involved in internal / external process improvement teams
  • Basic qualifications :

  • Master of Science degree (e.g. life science, medicine, clinical research, pharmacy etc.) or equivalent experience
  • Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field
  • Minimum of 3 - 5 years clinical research experience (experience may have been in Study Management, Field Monitoring or similar experience gained at another company)
  • Demonstrates high level of understanding of clinical research and clinical study management, and the associated regulatory, process and quality requirements
  • Strong knowledge / experience in project management and matrix team interactions
  • Good Polish and English written and verbal communication skills
  • Strong negotiation skills
  • Advanced / expert level of MS Office (PowerPoint, Excel, Word & Outlook)
  • Preferred qualifications :

    Please check Basic Qualifications.

    Why GSK? :

  • Working in a leading company from healthcare sector
  • Possibility of developing within the role and company’s structure
  • Supportive and friendly working environment
  • Company culture based on GSK values : patient focus, integrity, respect and transparency
  • Atmosphere of trust which let you grow professionally and act independently
  • Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund)
  • You may apply for this position online by selecting the Apply now button.

    Thank you very much for your interest in development opportunities with GlaxoSmithKline.

    Contact information :

    You may apply for this position online by selecting the Apply now button.

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    All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

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