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Data Manager Senior

  • Lieu:

    Barcelone, Espagne

  • Contact:

    Marta Dominguez Milanes

  • Type de poste:

    Permanent

  • Téléphone de contact:

    +31 (0)20 406 97 50

  • Secteurs d’activité:

    Pharmaceutical

  • Contact E-mail:

    Marta_Dominguez@oxfordcorp.com

We are looking for a Senior Clinical Data Manager (CDM) to lead the Data management team and determine the institution priorities. The main objective of this position is to generate high-standard data management procedures allowing investigators to conduct scientifically meaningful high-quality clinical research and trials. The SDM will be the responsible to develop procedures to maintain integrity of data while still maintaining Good Clinical Practices (GCP) and legal restrictions (GDPR, etc.).

Responsibilities

  • The SDM will be the responsible to develop procedures to maintain integrity data while still maintaining Good Clinical Practices (GCP) and legal restrictions (GDPR, etc.).
  • The SDM have to define, as a priority, the index of variables from observational studies in collaboration with the Head of scientific management.
  • Act as key expert in data management: training and supportingteam to data entry and data management procedures.
  • Actively contribute to the institution high scientific standards and develop processes to enhance the work.
  • Ensure the correct basis in terms of data management procedures for scientific analysis.
  • Develop metrics and status updates in order to follow Data Management achievements.
  • Organize and design Data management structure: tools, procedures, guidelines, etc

Requirements

  • University degree in science (preferred life science, psychology, medicine or statistics).
  • A biostatistics training or experience will be considered positively.
  • Minimum 3-4 year relevant clinical data management experience in Clinical Research (CRO, Pharma-industry, cooperative research groups, etc.).
  • Working knowledge of Clinical database applications such as EDC and CTMS.
  • Experience in database management programming (SAS, SPSS, R, SQL, etc…)
  • Perfect knowledge and training to GCP, etc. will be positively considered.
  • Spanish and Catalan preferred.
  • English required.
  • MedDRA and/or WHO coding., if applicable.
  • Knowledge of CDISC standards (SDTM and AdAM).