Vacancies

Senior CRA

Requirements:

  • Over 4-years professional experience, including full lifecycle of clinical trials (from project start-up phase to study closure)
  • Prior junior clinical staff mentorship experience
  • Strong communication skills
  • English fluency – both spoken and written
  • B.S. or higher degree in Life Sciences field

Responsibilities:

  • Full monitoring responsibilities: site selection, initiation, routine monitoring, and close-out visits
  • Site management, including protocol-specific training of the cross-functional study team at the clinical investigator sites
  • Mentorship and coordination of Junior CRAs
  • Close collaboration with PM, including assuming his/her responsibilities when required
  • Assistance in feasibility research studies

If you are interested in Senior CRA position, please send your CV and cover letter to @. Indicate “Senior CRA” in email subject, and we will get in touch.

 

Data Manager

Job Requirements

  • Bachelor degree or higher in a relevant scientific discipline;
  • Minimum 2 years of data management experience in pharma/CRO, or minimum 5 years in clinical operations (Phase I to IV);
  • Knowledge with various clinical EDC systems;
  • Knowledge of GCP (GCP certificate), GCDMP, FDA regulation and ICH guidelines, CDISC required;
  • Excellent communication, written and interpersonal skills both Russian and English;
  • Able to work with minimal oversight;
  • Proficiency with MS Word, Excel, Outlook, additional programming skill is a plus;
  • Able to prioritize and handle multiply tasks, manage junior staff and develop project management objectives.

Job Description

  • Review CT protocols with regards to appropriate data collection and data management;
  • Develop all relevant Data Management documentation (DMP, DVP, DMR etc.) and maintain data management study file;
  • Develop Case Report Forms;
  • Participate in database creation, data validation and testing;
  • To perform data review and cleaning activities (routine, ad-hoc and pre-DBL), participate in medical coding and SAE reconciliation;
  • To perform trainings for clinical study team and investigational sites teams

This position can be served as office-based and home-based depending on candidate.