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Clinical Trial Manager/Process Lead

New Jersey All, NJ

Posted: 09/05/2018 Job Type: Clinical Job Number: JN -092018-22462
  • Serves as subject matter expert and input into new SOPs on behalf of Trial Monitoring Organization (TMO)
  • Ensures compliance to and adequate training opportunities for new SOPs and Business Guidance
  • Serves as Lead SME on the monitoring processes as requested
  • Tracks deviations from Monitoring SOPs and ensures appropriate documentation is filed and corrective actions are taken
  • Identifies procedural gaps and drives correction with process improvements where applicable
  • Conducts and supports conduct of vendor qualifications as needed; documents and files qualification evidence appropriately
  • Ensures CAPA commitments are adequate, submitted and completed in a timely manner
  • Ensures audits and inspections are supported, tracked and outcomes requiring corrective action are managed
  • Reviews CAPAs and makes appropriate recommendations to keep consistent actions across TMO
  • Initiates and documents root cause investigations of critical issues in collaboration with Quality Assurance and Clinical Operations
  • Supports the generation and dissemination of Tactical Memos and Lessons Learned communication in collaboration with monitoring training
  • Leads the conduct of Trial Master File quality control checks
  • Ensures TMO compliance with required training by tracking and reporting compliance status for the Global, Regional and Country level organizations
  • Identifies gaps and assign action where needed to promptly gain compliance
  • Leads inspection preparation and execution as well as inspection readiness activities
  • Supports registration trial readiness by leading the planning and conduct of an annual self-assessment and facilitates spot checks for TMO in conjunction with that being done at the study level by the clinical team
  • Escalates issues to TMO management and CQA in a timely manner
  • Ensures that actions required of TMO are appropriately taken
  • Ensures procedural deficiencies within TMO are corrected and prevented
  • Liaises with Regional Process Control Managers (rPCM) to ensure local TMO quality is acceptable
  • Leads inspection response development and implementation as required by the business
Requirements:
  • College or university degree with significant life science experience; Advanced degree preferably in life sciences
  • A minimum of 8 years of Clinical Research experience
  • Trial Management with CAPA experience
  • Process review and improvement experience
  • Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations
  • Experience working in matrix environment and in global teams

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