The Role:
- Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
- As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Manage project in a timely manner in adherence with ICON's SOP's, ICH, GCP and appropriate regulation and liaise with other department managers as necessary.
- Delivery of projects in accordance with the contract, timelines and study budget
- Identification and review of change orders for the budget
- Attend and present at client Investigator, Kick-Off and client meetings
- Co-Development MIRA Project Set-up
- Ensure all necessary study specific training is provided to study team to improve performance and knowledge.
Provide coaching / mentoring as necessary.
- Management of eCRF development process
- Development/ Review/ Maintenance of all trial documentation (Charter, eCRF, SRS, ReviewerTraining Manuals)
- User Acceptance Training and demonstration of eCRF
- Data reconciliation
- Primary client and CRO contact; develops successful working relationships with client / CRO
- Preparation and management of meeting agendas and minutes
- Prepare / Approve Project Reports
- Management of Study Centres
- Coordinates readers and review sessions
- Conducts reader training with support of Project Director
- Monitors Offsite Assessments/Blinded Reads
- Quality Control of Offsite Assessments/Blinded Reads
- Ensures all management/ tracking systems are up to date
- Provide regular feedback to senior management on project status, client satisfaction and staffing issues.
- Manages Data Management Lead for scheduling and preparation of data deliveries as required
- Participate in BD activities as appropriate
- Supports internal, client, and regulatory audits
- Ability and willingness to travel
- Participate in interview as required
- Travel (approximately 35%) domestic and/or international
- Other duties as assigned