Worldwide Clinical Trials
Worldwide Clinical Trials
Worldwide Clinical Trials este o organizație globală de cercetare clinică pe bază de contract, care sprijină companiile farmaceutice și de biotehnologie pe parcursul întregului ciclu de dezvoltare a medicamentelor. Cu o experiență de peste 30 de ani, compania oferă servicii de monitorizare clinică, gestionare a datelor, recrutare a pacienților și consultanță de reglementare în domenii terapeutice precum oncologia, cardiologia și bolile rare. Abordarea sa combină expertiza vastă în studiile clinice cu sprijin personalizat și soluții adaptate studiilor complexe.

Clinical Data Management Manager – United States Remote

Lead clinical data management teams, study delivery, budgets, quality, and process improvement for Worldwide Clinical Trials. The role combines team leadership, sponsor engagement, and operational oversight within a global contract research organization.

Descriere

  • Lead assigned clinical data management teams and projects, overseeing study execution and budgets
  • Serve as the main contact for internal and external escalations related to assigned studies
  • Represent Worldwide Clinical Trials in sponsor governance meetings
  • Assign staff to projects based on their capabilities and competencies
  • Provide team oversight, training, mentoring, and career development support
  • Confirm appropriate project resourcing and address operational or budget risks
  • Handle performance-related escalations involving team members
  • Communicate upcoming staff availability to Data Management leadership to support utilization continuity
  • Assist Business Development with proposals and sponsor presentation materials
  • Participate in sponsor audits, regulatory inspections, and third-party meetings
  • Act as a subject matter expert for assigned Data Management processes when needed
  • Evaluate and improve process effectiveness and efficiency
  • Deliver process training and serve as a central contact for related questions
  • Lead quality issues, including root-cause analysis and CAPA activities when required
  • Maintain and revise QMDs and other process guidance documents
  • Coach and mentor members of the Data Management department
  • Direct departmental process improvement and efficiency initiatives
  • Complete additional duties as assigned

Cerințe

  • Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related field, or equivalent relevant experience
  • At least nine years of clinical data management or related experience in the pharmaceutical, biotechnology, or medical device industry
  • Two to four years of line management experience
  • Expertise in clinical-trial data management best practices and technologies
  • Advanced knowledge of clinical trial operations and protocol documents, including protocols, statistical analysis plans, CRFs, and study reports
  • Strong project management capabilities, including oversight of data management teams, operations, and budgets
  • Experience with recruitment, career development, and performance reviews as a line manager
  • Exceptional attention to detail
  • Strong written and verbal communication abilities
  • Effective interpersonal and communication skills for working with cross-functional internal and external teams
  • Ability to analyze issues and solve problems independently

Beneficii

  • Benefits package varies by location
  • Transparent compensation practices with a focus on pay equity

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