Regeneron je biotehnološko podjetje, ki odkriva, razvija in trži zdravila za resna in nezadostno obravnavana zdravstvena stanja. Njegove raziskave zajemajo alergije, bolezni srca in ožilja ter presnovne bolezni, nevroznanost, onkologijo, hematologijo, oftalmologijo in redke bolezni. Regeneron s povezovanjem bioloških raziskav in napredne tehnologije razvija biološka in genska zdravila, namenjena reševanju kompleksnih potreb zdravstvenega varstva. Podjetje v okviru svojega širšega poslanstva izboljševanja oskrbe bolnikov poudarja tudi enakost na področju zdravja, okoljsko odgovornost, znanstveno izobraževanje in etične poslovne prakse.
Clinical Study Specialist at Regeneron
Support Regeneron clinical trial teams by coordinating study data, sites, reporting, and close-out activities. Help keep studies on track from site activation through completion.
Opis
- Support clinical study teams with technical and administrative work across trial programs.
- Help keep studies on schedule from site activation through close-out.
- Prepare reports and metrics in formats suitable for analysis.
- Coordinate study team meetings, including agendas and minutes.
- Compile information for feasibility reviews and site selection.
- Assist with reviewing study documents and reference materials.
- Monitor site activation, enrollment, and monitoring visits against plans.
- Raise issues and delays, and track investigator and site status as well as registry postings.
- Follow up on scheduled reports and reconcile trial master files with guidance from the study lead.
- Contact sites as directed and maintain site details and working relationships.
- Assist with study close-out and support oversight of external vendors.
- Assess how new information may affect ongoing trials.
- Take part in standard operating procedure updates and departmental initiatives.
- Suggest ways to improve processes.
Zahteve
- Bachelor’s degree and at least two years of industry-related clinical experience.
- Ability to develop working knowledge of trial management systems and Microsoft applications, including Project, PowerPoint, Word, and Excel, as well as 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.
Ugodnosti
- Annual bonuses or other incentive plans.
- Equity awards.
- Pension or retirement benefits.
- 401(k) plan with company match.
- Health and wellness programs.
- Fitness centers.
- Medical, dental, vision, life, and disability insurance.
- Paid time off.
- Family support benefits.
- Reasonable accommodations during recruitment where required.