Covance Bus Ops Coordinator II in Shanghai, China
The Associate of Process Management,ChinaClinical Trial Management Office (CCTMO)providescountry 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. TheAssociate of Process Management (CCTMO)will work closely with team members withinCCTMO to support the operations in defining process performance requirements in order to hold country operational leaders accountable for their performance.The Associate of Process Managementis also responsible for providing expert process assistance to local project teams as required.
Collaborate with other Process Teammembersto 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/ trackprocess improvement projects to agreed scope and timelines
To perform stakeholder impact analysis and develop communication and training plans for the roll out of process improvementsworking with Clinical Training members inCCTMO
Develop communication and training materials to support execution of processes at operational / project level. Roll out new processeswith Clinical Training Team members withinCCTMO
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 Teammembers, 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 inChinaCTO
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 ofCCTMO as secondary responsibility
Management CAPA as CAPA Coordinator
Act as primary point of contact for allissue/CQI
Review and provide input for CAPA responses ensuring consistency acrossissues/CAPAs
Track and maintain CAPAs in state of compliance
Provide regular reports/updates to Country Leadership team regardsissue/CAPAperformance and trend
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
Masters or other advanced degree.
Detailed knowledge of Covance and the overall structure of the organization.
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 skillswithminimal supervision
Excellent communication, facilitation and presentation skillsand 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
Job Number 2018-20474
Job Category Clinical Operations
Position Type Full-Time
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