CORE JOB TASK
·Implement and deliver the agreed upon R&G Yearly Quality Control (QC) plan which includes risk management, to assist Clinical Operations to deliver compliance activities with relevant ICH, GCP, country regulations and guidelines.
·Conduct co-monitoring per QC plan, mentor and coach CRA when applicable.
·Support Clinical Operations team in preparing for sponsor audits and provide input into the generation of timely and appropriate audit response plans and assisting in preparation and responses for regulatory authority inspections
·Provide compliance support by answering questions or providing advice on GCP, SOPs, regulations and guidelines and bring issues to the attention of Clinical Operations Head as appropriate
·Participate in R&G and department system/standards improvement activities.
·Contribute to the development of and responsible for implementation and delivery of specific initiatives as defined and agreed upon.
·Work as the project manager and faculty to conduct instructor-led training to Clinical Operations on GCP, SOPs and related regulations or guidelines.
·Review, revise, write and implement, as required, Clinical Operations SOPs.
·A Bachelor Degree in a medical, health, or science related are, or a nursing degree.
·Minimum of 3 years related experience in clinical trial management or related areas including at least 2-year experience in Clinical Operations and 1 year experience in Quality Control or Quality Assurance is preferred.
·Good understanding of Phase I – IV clinical trials quality control principles, clinical monitoring procedures, all relevant GCP guidelines and of local and international regulations.
·Knowledge of medical terminology and high proficiency in Microsoft Word / Excel / Powerpoint / Outlook
·Excellent, interpersonal, communication and organizational skills.
·Good team player, self-motivated and attention to details.
·Strong customer focused sensitivity towards internal and external customers.
·Competent in written and oral English.
·Able to travel when required.