Clinical Data Management Director

hace 3 semanas

Barcelona, Barcelona, España All Options A tiempo completo
Job Title: Associate Director Clinical Data Manager

A great opportunity has opened within the Data Monitoring, Management and Innovation department to further strengthen our Clinical Data Management team.

About the Role:

As an Associate Director Clinical Data Manager, you will play a crucial role in managing and overseeing clinical data management activities within the organization. You will be responsible for ensuring the integrity, accuracy, and completeness of clinical trial data, while also coordinating a team of clinical data management professionals in a matrix setting.

Key Responsibilities:
  • Accountable for all Clinical Data Management (CDM) related deliverables in assigned global (Phase I-IIIb) trials or programs of varying complexity
  • Provide CDM leadership for assigned trial(s)/program(s), take global accountability and serve as the CDM representative at the study/program level
  • Demonstrate project management and operational expertise in the strategic planning and delivery of CDM deliverables at study/program level, e.g. planning timelines and resources, risk identification and management, status tracking, internal and external stakeholder management etc.
  • Define and execute risk-based data collection, cleaning and quality assurance strategies for eCRF and external data (including coding)
  • Ensure the accuracy, integrity, and completeness of clinical trial data through comprehensive data review and validation activities
  • Ensure quality of clinical database/deliverables (incl. eCRF and external data) as well as submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
  • Act as primary point of contact within CDM for any HA submission related activities (e.g. preparation of briefing books, attending HA meetings as requested)
  • Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s)
  • Contribute to the development and maintenance of data management SOPs, work instructions, and best practices
  • Lead process improvement initiatives and drive innovation in the field of Clinical Data Management
Additional Responsibilities for Program Assignments:

Demonstrate good understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned studies in an assigned program/indication e.g.

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