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Hiro

7 days ago

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该职位来源于猎聘 Key Responsibilities:

Allocate workload and site assignments within the clinical monitoring team.
Ensure quality of the clinical monitoring deliverables within a project and maintain proper visibility of its progress by the use of tracking tools. May include the development of the Clinical Management Plan (CMP).
Ensure efficient dissemination of information across the CRA team.
Interact with the client and other functional departments related to clinical monitoring activities and deliverables.
Ensure alignment of clinical activities to budget.
Identify quality issues within the study through regular review of site communications, monitoring visit reports, etc. to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Support development of study materials and present at investigator or study launch meetings.
Support the identification of out of scope activities including the completion of clinical monitoring aspects of change orders.
Participate in business development proposals, defense meetings and proposal development.
Oversee, coach and mentor project staff
May evaluate staff’s competency to perform visits/site contact independently via Performance Assessment Visits (PAVs) according to company standards and process Preferred Experiences and Skills
Preferred 6 years prior clinical research or monitoring experience, minimum 1 year in a Clinical Trial Manager or equivalent lead role.

Part of the required years of clinical experience can be compensated by

Study Start-Up experience.

Demonstrated ability to lead and align team in the achievement of project milestones.
Demonstrated capability of working in an international environment across regions, countries, and time zones.
Knowledge of basic financial principles
Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements.
Strong organizational skills.
Must demonstrate good computer skills.
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade.
Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues