Data Management Lead I and II

hace 3 días

Medellín, Antioquia, Colombia Parexel A tiempo completo

Parexel is seeking to hire multiple Data Management Leads I and II to support our FSP team.

These are remote roles, open to candidates based anywhere in Argentina, Brazil, Mexico, and Colombia.

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.

Key Accountabilities:

  • 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.

Bid Pursuits and Proposals

  • Support experienced DML in Bid Pursuit preparation meetings.
  • Provide input on DM slides, as appropriate.

Project Quality Management and Compliance

  • Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
  • Maintain inspection-ready Trial Master File.
  • Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements.
  • Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.
  • Support and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate.

Project Financial and Resource Management

  • Ensure appropriate project level resourcing of staff and staff assignments.
  • Identify and request functional staff necessary for the project team.
  • Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools.
  • Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope.

Company Initiatives

  • May provide Data Management functional input, considering the impact of the initiative and the impact on Data Management and Parexel as a whole.
  • May support other functions as appropriate to provide meaningful functional feedback on the initiative.
  • Ensure Parexel-requested information entered into management systems is accurate and regularly updated.

Training

  • Maintain training compliance as per Job Roles assigned, including On-the Job training.
  • Deliver Project Specific Training to internal DM team.
  • Address training needs, as per Development Goal/s identified.

Skills:

  • Written and oral fluency in English.

Knowledge and Experience:

  • 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.
  • Demonstrates technical aptitude.

Education:

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

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