Upsilon Global

Senior Clinical Data Manager

Location
Italy (IT)
Salary
Up to €60,000
Posted
05 Oct 2020
Closes
04 Nov 2020
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

 

Senior Clinical Data Manager

Italy

 

MAIN RESPONSIBILITIES

The Senior Clinical Data Manager will be responsible to provide the procedural and practical hints to create the new Biometrics Unit

He/she will also:

  • Collaborate with the Clinical Department in developing and finalizing the eCRF;
  • Collaborate with the Clinical Department and the Biostatistician to define edit checks and protocol deviations;
  • Write the data management plan (DMP), data validation plan (DVP), CRF and other relevant data such management study documents such as IVR/IWR System specification;
  • Perform data cleaning and discrepancy management;
  • Perform the medical coding;
  • Perform the SAE reconciliation;
  • Collaborate with SAS Programmer and PMs in generating reports/tables/ figures /listings for the clinical department;
  • Collaborate with SAS Programmer and PMs to implement metrics for the centralized monitoring;
  • Collaborate in establishing and maintaining SOPs related to Biostatistics;
  • Fluent with MedDRA and WHO coding;
  • Experience in centralised monitoring

REQUIREMENTS

  • More than five years of experience as Senior Clinical Data Manager in a CRO and/or Pharma;
  • Knowledge of Clinical Database Management Systems;
  • Knowledge of the data management full cycle;
  • SAS knowledge;
  • Excellent knowledge of the English language

For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +44. (0) 20. 3. 87. 5. 99. 66 or email ‘ applications (at) upsilonglobal . com’