Requisition ID: CLI008551
This role will be key to ensure business continuity in the area of monitoring in clinical research. The person is responsible to manage a team of 6-12 CRAs and to ensure excellent study performance with strict adherence to local regulations, SOPs and ICH GCP. As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs.
The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.
Responsibilities include, but are not limited to:
-Work allocation, staff development and performance appraisal.
-Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
-Work with CRA and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
-Interacts with sites as needed to resolve site operational issues to meet commitments in a timely manner.
-Attend local Investigator Meetings as necessary.
-Interface with GCTO partners on clinical trial execution.
-Escalates site performance issues to Clinical Research Director (CRD).
People and Resource Management:
-Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.
-Support and resolve escalation of issues from CRAs.
-Liaise with local HR and finance functions as required.
-Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.
-Provides training, support and mentoring to the CRA to ensure continuous development.
-Ensures CRA compliance to corporate policies, procedures and quality standards
-More than 8~10 years clinical research background
-Bachelors degree in Science or equivalent healthcare experience
-People Management Experience
Job: Clinical Research Generic
Employee Status: Regular
Number of Openings: 1
Shift (if applicable):
Company Trade Name: MSD
Job Segment: Assistant Manager, Research Associate, Clinic, Clinical Research, Medical Research, Management, Research, Healthcare