Regeneron
Regeneron
Regeneron ir biotehnoloģiju uzņēmums, kas atklāj, izstrādā un komercializē zāles smagu un nepietiekami ārstētu slimību ārstēšanai. Tā pētniecība aptver alerģijas, sirds un asinsvadu slimības, vielmaiņas slimības, neirozinātni, onkoloģiju, hematoloģiju, oftalmoloģiju un retās slimības. Apvienojot bioloģiskos pētījumus ar progresīvām tehnoloģijām, Regeneron izstrādā bioloģiskos un gēnu medikamentus, kas paredzēti sarežģītu veselības aprūpes vajadzību risināšanai. Uzņēmums savā plašākajā misijā uzlabot pacientu aprūpi uzsver arī veselības vienlīdzību, atbildību par vidi, zinātnisko izglītību un ētisku uzņēmējdarbības praksi.

Clinical Study Specialist

Support clinical trial operations at Regeneron, a medicines developer, by tracking study progress, documentation, sites, vendors, and close-out work.

Apraksts

  • Prepare clear reports and study metrics for analysis.
  • Arrange study team meetings and prepare agendas and minutes.
  • Compile information for feasibility reviews and site selection.
  • Help review study documents and reference materials.
  • Monitor site activation, enrollment, and monitoring visits against plans.
  • Raise issues and delays, and track investigator and site status and registry postings.
  • Follow up to ensure scheduled reports arrive on time.
  • Reconcile trial master files with guidance from the study lead.
  • Communicate with study sites and maintain contact details and working relationships.
  • Assist with study close-out activities.
  • Help oversee third-party vendors when needed.
  • Assess how new information may affect ongoing trials.
  • Take part in standard operating procedure updates and departmental initiatives.
  • Suggest ways to improve processes.

Prasības

  • Bachelor’s degree and at least two years of industry-related experience in a clinical setting.
  • Ability to develop working knowledge of trial management systems and Microsoft applications, including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, and TMF.
  • Basic familiarity with medical terminology and clinical drug development.
  • Awareness of ICH/GCP.
  • Proactive and self-disciplined, with the ability to manage deadlines and priorities effectively.

Priekšrocības

  • Annual bonuses or other incentive plans.
  • Equity awards.
  • Pension or retirement benefits.
  • 401(k) with a company match.
  • Health and wellness programs.
  • Fitness centers.
  • Medical, dental, vision, life, and disability insurance.
  • Paid time off.
  • Family support benefits.
  • Hybrid work flexibility.
  • Reasonable accommodations during recruitment where required.

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