Clinical Data Management Leader

hace 2 semanas

Barcelona, Barcelona, España All Options A tiempo completo

Job Summary:

We are seeking a highly skilled Clinical Data Management Leader to join our team at All Options. As an Associate Director Clinical Data Manager, you will play a crucial role in managing and overseeing clinical data management activities within the organization.

Your 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, including 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

Requirements:

  • 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

About All Options:

All Options is a leading company in the field of Clinical Data Management. We are committed to delivering high-quality data management services to our clients.

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