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Data Team Lead - Clinical Data Management

iqvia · Shanghai

New
Senior 🇬🇧 English
Clinical Data Management SAE reconciliation Data Management Plan (DMP) Project management

Job description

About the role

IQVIA is looking for a Data Team Lead in Shanghai to manage end-to-end delivery of data management services for single- and multi-service projects with minimal guidance, delivering quality results on time and within budget. The role provides leadership to the Clinical Data Management (CDM) team in project planning, execution and close-out, financial management, communications and milestone deliverables, while complying with GCPs, regulatory guidelines, SOPs and policies.

Key responsibilities

  • Act as the primary point of contact for the customer on data management deliverables, manage continuous improvement, issue escalation, workload projections and negotiate timelines, finances, processes and resources with guidance.
  • Meet regularly with the Data Operations team to ensure milestones meet timelines and quality, and act as escalation point for unresolved data issues.
  • Create and sign off data management plans (DMP), run a proactive quality management plan, track service performance and root causes, and resolve compliance issues.
  • Manage the SOW and budget, review monthly financial reports, track change orders, and with guidance act as project manager for single-service projects, including invoicing, and support the RFP process.
  • Contribute to process improvements, new tools and best-practice teams, and perform other duties as directed.

Required profile

  • Bachelor's degree in health, clinical, biological or mathematical sciences or a related field.
  • 3 years of direct data management experience, including at least 1 year as a CDM project lead; equivalent education, training and experience accepted.
  • Proven ability to manage study delivery through the full DM life cycle, including at least one medium Phase III study.
  • Comprehensive understanding of the clinical drug development process and ability to work with minimal supervision.

Required skills

  • Thorough knowledge of the data management process, including SAE reconciliation, external data vendor reconciliation and local laboratory data management.
  • Knowledge of medical terminology, pharmacology, anatomy and/or physiology.
  • Knowledge of Good Clinical Practices and applicable regulatory guidelines.
  • Excellent communication, customer service, teamwork, organizational, problem-solving and project management skills.

Questions fréquentes

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Source : ats:workday

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Published 17小时前

Expires 1个月后

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iqvia

Shanghai