Data Management Lead I and II

hace 4 semanas


Medellín, Antioquia, Colombia Parexel A tiempo completo

Parexel is seeking a Data Management Lead I and II to support our FSP team.

The Data Management Lead I provides leadership in all aspects of Data Management, managing timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management's single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.

The Data Management Lead II develops and manages timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaborate with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Acts as the Data Management's single point of contact to ensure that the contracted Data Management deliverables are being met — specifically in terms of timeliness financial management and quality.

Key Responsibilities:

  • Manage and coordinate the integration and utilization of all ancillary systems as appropriate.
  • Highlight issues/risks to delivery by understanding interdependencies. Support mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan.
  • Review and analyze metrics to derive meaningful summary of study health and trends.
  • Review of the Master Services Agreement, Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators.
  • Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs.

Requirements:

  • Experience in clinical research industry or similar field
  • Proven record of coordinating and supporting project teams
  • Basic understanding or willingness to learn and apply Parexel financial tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects
  • Basic understanding of or willingness to learn Clinical Study Team roles outside of Data Management
  • Full understanding or willingness to learn and apply relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
  • Awareness of/or willingness to learn SDTM/CDISC/CDASH standards
  • Awareness/potential prior experience in Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products.

Education:

Bachelor's degree and/or other qualifications in a science or clinical related industry.



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