Clinical Study Manager
Summary:
The Clinical Study Manager will work on both national and multi-national studies. The primary responsibility of this position is to manage clinical aspects of research projects on behalf of Micron for client companies.
Duties and Responsibilities
- Finding and assessing the suitability of sites to participate in specific projects
- Managing investigator meetings
- Liaising with clinical investigators to ensure good professional relationship
- Setting up / initiating investigative sites
- Managing individual centres and closing centres
- Managing projects in compliance with relevant SOPs
- Managing project budgets
- Co-ordinating activities of all study team members companies
- Ensuring all required documentation is collected and filed in relevant files in a timely manner
- Reporting status to Micron senior management
- Reporting status to client in a timely manner and in line with Micron's systems
- Ensuring confidentiality of project specifications
- Effectively assisting in management of vendor relationships
- Interacting with management and staff in central and local CRO/vendor
- Resolving issues within the study team
Minimum Job Requirements:
- Science degree or nursing qualification
- A minimum of 2 years experience in clinical research
- Experience of managing a clinical trial at national level (at assistant CSM level).
Knowledge, Skills, and Abilities Required:
- Ability to present at team, training and Investigator meetings etc.
- Good understanding of regulatory requirements and guidelines (e.g.ICH-GCP)
- Mature, intelligent and problem-solving approach to project issues
- Logical and systematic approach to managing several inter-related activities
- Self-discipline and timeliness in all working practices
- Ability to interact with team members in a constructive and helpful way
- Flexibility to assume other roles to enable projects to proceed irrespective of unavailability of other team members
- Diplomacy at all levels with fellow colleagues and client colleagues
- Excellent written communication skills
- Good computer skills and familiarity with data management procedures
- Professional appearance and manner