Data Management Lead II

2 weeks ago

Bloemfontein, Orange Free State, South Africa Parexel Full time
Data Management Lead II

Parexel is seeking a highly skilled Data Management Lead II to join our team. As a key member of our global data operations team, you will be responsible for providing leadership in all aspects of data management, including developing and managing timelines for study data deliveries, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock.
  • Collaborate with cross-functional teams, including Clinical, Biostatistics, Database Programming, Medical, and Medical Writing.
  • Ensure compliance with regulatory requirements, including ICH-GCP Guidelines and local regulatory requirements.
  • Manage and coordinate the integration and utilization of all ancillary systems as appropriate.
  • Highlight issues/risks to delivery by understanding interdependencies and define mitigations and drive to resolution with cross-functional stakeholders.
Requirements:
  • Strong experience in clinical research industry or similar field.
  • Proven record of coordinating and supporting project teams.
  • Good understanding of project tools, reports, and processes for management of project financials with regards to forecasting, revenue recognition, scope of work, and department budget for assigned projects.
  • Good understanding of Clinical Study Team roles outside of Data Management.
  • Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements, and Parexel SOPs and study-specific procedures.
  • Awareness of SDTM/CDISC/CDASH standards.
  • Strong technical skills, including knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products.
What We Offer:
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

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