职位描述:
CORE JOB TASK
* Lead CRC team.and supervise of the implementing and conducting clinical studies on site by CRC in accordance with applicable regulatio, GCP/ICH guidelines, and applicable SOPs.
* Generate clinical project plan including timeline projection and operation on site strategy.
* Design related associated Forms and CRC workbook
* Prepare and implement project-specific training programs and presentatio for internal and external clinical team,
* Participate in and provide support investigator meetings, including presentatio.
* Participate in CRC on site at fit time
* Be overall respoible for protocol compliance across all sites, and on-time study milestone delivery
* Provide regular co-operation on site and project status reports for both internal and external clients as agreed.
* Review CRC regular reports and correspondence. Make recommendatio regarding monitoring, safety, eligibility, enrolment, and data coistency, and be involved in issue escalation and resolution.
* Track and eure study budget according to the agreement.
* Mentor and coach CRCs and project manage (senior PM only).
* Provide input to study proposal and budgets as needed.
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 research and project management.
* Thorough undetanding of all relevant ICH-GCP guidelines and regulatio.
* Good verbal and written communication skills.
* Good team player, self-motivated and attention to details.
* Demotrated leadehip, influence and problem-solving skills.
* Strong customer focused seitivity towards internal and external custome.
* Must be able to travel.