Data Management Lead I and II

hace 1 semana


Medellín, Antioquia, Colombia Parexel A tiempo completo
Parexel Data Management Lead I and II

About the Role:

Parexel is seeking to hire multiple Data Management Lead I and II to support our FSP team. These are remote roles, open to candidates based anywhere in Argentina, Brazil, Mexico, and Colombia.

Key Responsibilities:
  • Provide leadership in all aspects of Data Management, managing timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock.
  • Collaborate with relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing, etc.) across all geographies.
  • Act as the Data Management's single point of contact to ensure that contracted Data Management deliverables are being met, specifically in terms of timeliness, financial management, and quality.
  • 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 summaries of study health and trends.
  • Review 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.
  • Support experienced DML in Bid Pursuit preparation meetings.
  • Provide input on DM slides, as appropriate.
  • 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 systems 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.
  • Ensure appropriate project-level resourcing of staff and staff assignments.
  • 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.
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.
  • Demonstrates technical aptitude.
  • Bachelor's degree and/or other qualifications in a science or clinical-related industry.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
How to Apply:

Please submit your application, including your resume and cover letter, to [insert contact information].



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