Manager-Country Study Management - Shanghai, 中国 - Lilly

    Lilly
    Lilly Shanghai, 中国

    2周前

    Lilly background
    全职
    描述

    We're looking for people who are determined to make life better for people around the world.

    Primary Responsibilities

  • Accountable for study timeline, quality and budget plan and delivery at country level
  • Provide operational strategic input to early protocol development and study timelines
  • Lead Country level feasibility
  • Lead CRA team to identify, screen, evaluate and select sites partnering with quality team to ensure site qualification for a specific study participation
  • Coordinate and facilitate study training planning and implementation
  • Responsible for country level site activation process, timeline, risk management, contract budget approval & control
  • Actively coordinates, participates and presents in AST, ISST and/or SIVs as required
  • Provide input into study related vendors selection, such as vendors for quick start up, recruitment, etc., review and approve vendor payments, oversight vendor deliveries
  • Coordinate and facilitate enrollment readiness including all local set-up activities,CFDA study information online registration and HGRAO submission in preparation for FPV
  • Lead CRAs to develop enrollment plans ensuring appropriate risk/mitigation at each site in order to meet targets
  • Provide input and/or develop and maintain country level monitoring plans as required
  • Oversights monitoring intervals, SDV/SDR backlog and site compliances
  • Monitoring oversight including sampling review monitoring visit reports, meetings with Study Report Reviewer Specialist and COM
  • Oversight site-level data entry and query resolution
  • Co-ordinate and conduct study based co-monitoring with CRAs as required
  • Accountable for country level Issue Management and Protocol deviation review
  • Oversight of study timeline, SDV status and data query resolution as planned
  • Verify and approve site payment
  • Lead and ensure site self check process within planned time
  • Ensure timely closeout site summary and CSR stamping
  • Create and maintain Country level system such as eTMF and sCTMS with completeness and high quality
  • Oversee site level TMFs to ensure completeness, accuracy and updated in a timely manner
  • Collaborate in the preparation of local quality/compliance reviews, internal audits and regulatory inspections and ensures adequate and timely CAPA follow up
  • Identify quality issues within the study to implement appropriate corrective action plans or escalate to appropriate level for resolution

    • Minimum Qualification Requirements:

  • At least Bachelor's degree or equivalent work experience in a scientific or health-related field
  • Minimum of 3-5 years' CRA or 2 years' country study manger or similar position working experience in Clinical Trials
  • Fluent English communication in reading, writing and spoken formats
  • Strong self-management and organization skills
  • Project management skills
  • Strong problem solving and communication skills (both verbal and written)
  • Good computer Microsoft office software skills

    • Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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