Covance

  • Bus Ops Coordinator II

    Job Location(s) CN-Beijing | CN-Shanghai
    Job Number
    2018-20474
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    The Associate of Process Management, China Clinical Trial Management Office (CCTMO) provides country support to the country head of Clinical Trial Operations, to identify trends in process performance and formulating process improvement concepts, gaining formal approval to execute and running and managing these projects to completion. The Associate of Process Management (CCTMO) will work closely with team members within CCTMO to support the operations in defining process performance requirements in order to hold country operational leaders accountable for their performance. The Associate of Process Management is also responsible for providing expert process assistance to local project teams as required.

    • Collaborate with other Process Team members to identify process improvement opportunities based on process performance data – operational, quality, financial, project governance, audit and other sources
    • To prepare local project charter and scope for process improvement projects for consideration by the project review board
    • To implement / run / manage / execute / track process improvement projects to agreed scope and timelines
    • To perform stakeholder impact analysis and develop communication and training plans for the roll out of process improvements working with Clinical Training members in CCTMO
    • Develop communication and training materials to support execution of processes at operational / project level. Roll out new processes with Clinical Training Team members within CCTMO
    • May act as process owner for local assigned SOPs as needed
    • Develop systems & tools to support & track process compliance
    • Provide expert advice and counsel / opinion on matters of process compliance / interpretation relevant to specific functional / process group
    • Act as point person for process clarification questions received from relevant operational teams
    • Provide communication of process improvements to the country operational teams
    • Working with other Process Team members, hold regular process data review sessions with local management teams
    • Promote and implement best practice for assigned functional / process area
    • Propose and lead strategic modifications / upgrade of current process / tool / tracking system to improve efficiency in China CTO
    • Enhance process / tool / tracking system in a timely manner based on country operations team’s feedback
    • May act as CAPA Coordinator
    • May Support CQC after pass training and assessment by RQCM
    • Take up the responsibilities of Clinical Training team of CCTMO as secondary responsibility

     

    Management CAPA as CAPA Coordinator

    • Act as primary point of contact for all issue/CQI
    • Review and provide input for CAPA responses ensuring consistency across issues/CAPAs
    • Track and maintain CAPAs in state of compliance
    • Provide regular reports/updates to Country Leadership team regards issue/CAPA performance and trend

    Education/Qualifications

    Required:

    • University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
    • Broad knowledge of drug development process and client needs.
    • Thorough knowledge of Covance SOPs

    Preferred:

    • Masters or other advanced degree.
    • Detailed knowledge of Covance and the overall structure of the organization.

    Experience

    Minimum Required:

    • At least 2 years of clinical research experience, e.g. as Clinical Research Associate or Project Manager in the CRO or Pharmaceutical industry
    • Comprehensive understanding of project management, site start up, site monitoring and study site management requirements with documented knowledge of trouble-shooting and issue resolution
    • Demonstrated ability to handle multiple competing priorities
    • Experience leading or participating on significant change initiatives. Familiarity with change management models is preferred
    • Planning and organizational skills with minimal supervision
    • Excellent communication, facilitation and presentation skills and confidence presenting to senior management
    • Good conflict management skills
    • Good computer skills with a working knowledge of a range of computer applications.
    • Excellent planning, time management and organization skills
    • Ability to work independently

     

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