Duties: The clinical research manager will be responsible for managing logistics of clinical trial process and the administration of clinical trials. He/She will conduct in-house and on-site monitoring, filing and clinical trial administration, assist with third party auditing. Under the guidance of the Director of Regulatory Affairs, he/she will adhere to SOP's, Good Clinical Practice and FDA regulations.
The candidate will assume overall responsibility for the preparation of protocols. Develop outsourcing strategy including selecting CROs and managing CROs performance. Ensure GCP compliance in all clinical trials. Participate in training at start-up and initiation meetings, as well as continuous training of study coordinators. Develop systems to track status of projects , using project management tools to balance scope, schedule and resources for trails. Assists with financial management of clinical trial program including budget planning and resource allocation
Qualifications: The minimum of a Bachelor's degree and 5 to 7 years of experience, or equivalent combination of education and experience, required.
