Clinical Data Manager

по договоренности

Требуемый опыт работы
От 3 до 6 лет
Занятость
Полная
График
Полный день
Образование
Высшее

The leading therapeutically contract research organization (CRO) that applies deep therapeutic expertise to help clients achieve their drug development goals. The global presence of clinical research worldwide, the full range of development services offered, and the innovative use of patented and advanced technologies create an environment that allows you to focus on the optimal opportunities for successful product development.

Kelly

Санкт-Петербург м. Невский проспект
www.kellyservices.ru/
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Working conditions

  • Salary is discussed.
  • Life insurance, Business Travel Accident Insurance.
  • Private Healthcare (Medical insurance) for the associate and for 1 relative.
  • Sick leave benefit (10 days paid on average salary per year).
  • Childbirth and Supplemental Bereavement compensations.
  • Free online English Lessons.
  • Working in a friendly ambitious team.

Responsibilities


  • To manage each of the data management projects to which assigned; provide leadership to the corresponding data management teams.
  • To represent CRO in all dealings with Sponsors with respect to the Data Management aspects of the projects to which assigned.
  • To liaise with the Director, Data Management at regular intervals to discuss progress and any issues outstanding.
  • To take responsibility for staff training for all projects to which assigned; both direct involvement in training and supervision of staff assigned to training.
  • To ensure that all data management operations are conducted to SOPs; contribute to the ongoing revision/improvement of these SOPs.
  • To write and validate Manual and SAS checks.
  • To set-up processes for reconciliation and perform reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory).
  • To perform verification and User Acceptance Testing of configured databases..
  • To specify and review SAS listings/SAS tables for assigned projects.
  • To create and review CRF and eCRF completion guidelines, EDC system manuals and access instructions.
  • To train others to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data.
  • To liaise with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees (CEC) within clearly defined guidelines for matters concerning the processing of data.
  • To ensure that adequate QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects.

Requirements


  • At least 4-5 years working at CRO in DATA MANAGEMENT area.
  • At least 3 years of managerial experience as CLINICAL DATA MANAGER or relevant.
  • Good leadership and communication skills.
  • Upper-intermediate English.

Место работы

Санкт-Петербург м. Невский проспект

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