Accountabilities
1. Inspection Readiness
Perform required tasks according to the inspection readiness plan including
perform on site visit, in house TMF review, organize regular meetings, etc.
● Work closely with CTMs within TCM CO to ensure inspection readiness plan is
implemented for the assigned trials
● Familiarize with assigned trials for inspection readiness and
lead/coordinate inspection readiness activities for the assigned trials
● Collate progress / status report of inspection readiness preparation
activities for assigned trials and communicate such status / progress to
stakeholders
● Support CTMs to ensure gaps identified during inspection readiness are
appropriately addressed e. Collaborate with QM colleague to perform trend / GAP
analysis for the trials that undergo inspection readiness, if required; and
work with trial team to develop preventative measurements; to ensure
preventative measurements are implemented
2. Quality Management
● Perform QC visits as delegated by CTM to determine if the trial conducting
and clinical monitoring done by CRA is in compliance with the protocol,
Standard Operating Procedures (SOPs), ICH-GCP and all applicable regulations to
ensure that the rights and well-being of the patients are protected and that
the study data are accurate and reliable
● QC visit both conduct in-house and on-site, review of safety information,
review of facilities, and review of CRFs and source documentation
● Complete QC visit report, ensure observations from such visits are properly
addressed
● Follow-up on QC visit/site issue review/CTMF review/audit/inspection issues
as well as corrective action and preventive action (CAPA) with CRA and CTM
● Assist the CTM in the relevant activities and tasks in relation to audit and
inspection preparation as well as logistic including in the review and response
to audit/inspection queries as well as any audit/inspection reports



Minimum Education/Degree Requirements
Bachelor Degree in Life Sciences, preferably in Medicine, Pharmacy or Health
Sciences.



Required Capabilities (Skills, Experience, Competencies)
1. Minimum 5 years' experience in clinical operations, including at least 1
year quality relevant experience
2. Project management experience or equivalence will be a plus
3. Excellent understanding of ICH GCP, and other applicable regulations,
policies related to clinical trials
4. Strong Quality sense and proven records of high-quality standard
5. Good communication and organization skills
6. Fluent in reading, writing and speaking English
7. Willing to travel 50%