Clinical Data Manager

St. Petersburg
1.5 years
Contract, full-time

The responsibilities:

  • Management of clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines;
  • Development of Data Management Plans;
  • Development of Case Report Forms (electronic and/or paper forms);
  • Development of clinical trial databases, including eCRF, user requirements, edit rules/checks, query logic and data validations;
  • Assistance in Data Management tasks;
  • Participation in system testing and test case validation;
  • Organizing training sessions within the department;
  • Overseeing the process of archiving, storing, updating and retrieving data management documents;
  • Data Cleaning (including a third referee role for paper-based studies) and Query tracking and management;
  • Setup and review of medical and medication terms coding using standard coding dictionaries (MedDRA, WHO Drug, etc.), and coding of other specific terms coding (according to custom dictionaries);
  • Initiation and review of SAE and external data reconciliation.

Requirements:

  • MD or university degree in Life Sciences;
  • At least 1.5 years in total of work experience in Clinical Data Management;
  • English: upper intermediate and above;
  • Excellent verbal and written skills;
  • Good organizational, interpersonal and team skills;
  • Demonstrable computer skills (MS Office Applications);
  • Experience with medical records will be an advantage.

We offer:

  • A challenging job in with a highly qualified team;
  • An employee-friendly working environment;
  • A competitive salary;
  • Professional growth in the field of clinical research.

 

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If you have not found what you have been looking for, send a request to info@oct-clinicaltrials.com.

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