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