Clinical Operation Manager(COM)

[담당업무]

• Responsible for the operation and management of the Clinical Operation Team and responsible for the planning, implementation and management of clinical trials.

• Provide consultation to sponsors regarding clinical trials development process, strategy, and plans as needed. Work with Business Development Team for supporting new business opportunities.

• Assignment of PM and CRA in charge of conducting clinical trials.

• Actively provide guidance and review of the scope of work, objectives, timelines, quality of deliverables, and other clinical project management activities for studies and programs.

• Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored

  training experiences.

• Maintain and confirm clinical trial list and update periodically.

• Review the establishment, revision, modification and abolition of SOP or appoint a reviewer with in the team to delegate.

• Working with staff to identify quality issues within the study and coaching on resolution of issues,including implementation of corrective action plans and escalation. Participate and lead quality

  control or process improvement initiatives.

• Designate a back-up person in the absence of PM for a long time.

• Review and approve Project Management Plan, Monitoring Plan.

• Perform as a line manager.

• Time and resource allocation and management of the clinical operation team.

[지원자격]

• Bachelor’s degree and above in health or science related field.

• 10 years' clinical research experience including 3 years' leadership experience is preferred.

• Excellent working knowledge of GCP, company standard operating procedures, local regulations.