Job Summary
This person is responsible for managing client studies within Clinical Operations and or Clinical Outcomes.
Job Responsibilities
* 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, Reviewer Training 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 Centers
* 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
Requirements
Minimum of 3 years' Project Management experience (With at least 2 years hands-on in Imaging)
Minimum Bachelor's Degree in Science or other relevant discipline and appropriate experience