CORE JOB TASK

·Implement and deliver the agreed upon R&G Yearly Quality Control (QC) plan which includes risk management, to assist Clinical Operatio to deliver compliance activities with relevant ICH, GCP, country regulatio and guidelines.

·Conduct co-monitoring per QC plan, mentor and coach CRA when applicable.

·Support Clinical Operatio team in preparing for spoor audits and provide input into the generation of timely and appropriate audit respoe pla and assisting in preparation and respoes for regulatory authority ipectio

·Provide compliance support by awering questio or providing advice on GCP, SOPs, regulatio and guidelines and bring issues to the attention of Clinical Operatio Head as appropriate

·Participate in R&G and department systemtandards improvement activities.

·Contribute to the development of and respoible for implementation and delivery of specific initiatives as defined and agreed upon.

·Work as the project manager and faculty to conduct itructor-led training to Clinical Operatio on GCP, SOPs and related regulatio or guidelines.

·Review, revise, write and implement, as required, Clinical Operatio SOPs.

MINIMUM REQUIREMENTS

·A Bachelor Degree in a medical, health, or science related are, or a nuing degree.

·Minimum of 3 yea related experience in clinical trial management or related areas including at least 2-year experience in Clinical Operatio and 1 year experience in Quality Control or Quality Assurance is preferred.

·Good undetanding of Phase I – IV clinical trials quality control principles, clinical monitoring procedures, all relevant GCP guidelines and of local and international regulatio.

·Knowledge of medical terminology and high proficiency in Microsoft Word / Excel / Powerpoint / Outlook

·Excellent, interpeonal, communication and organizational skills.

·Good team player, self-motivated and attention to details.

·Strong customer focused seitivity towards internal and external custome.

·Competent in written and oral English.

·Able to travel when required.