CQC Assessor

Job Overview:

The Senior Process Associate, 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 Senior Associate of Process Management (CCTMO) will work closely with team members within CCTMO and Global CTMO to support the operations in defining process performance requirements to hold country operational leaders accountable for their performance.

Summary of Responsibilities:

• These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
• 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 and tools to support and 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.
• Oversights activities in CCTMO and provides appropriate supervision to CCTMO members.
• May act as CAPA Coordinator.
• 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 applicable issue/CQI.
• Review and provide input for CAPA responses ensuring consistency across.
• Track and maintain CAPAs in state of compliance.
• Provide regular reports/updates to Country Leadership team regards issue/CAPA performance and trend.
• Identify trends in quality issues/findings and develop broad, long term preventative strategies to reduce /eliminating common findings.

Qualifications (Minimum 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 Fortrea SOPs.

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 troubleshooting 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.

Preferred Qualifications Include:

• Master’s or other advanced degree.
• Detailed knowledge of Fortrea and the overall structure of the organization.

Physical Demands/Work Environment:

• General Office Environment or Home-Based Office.

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