Project Manager II, IDEA
About the role
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- Recognize, exemplify and adhere to ICON's values which center 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.
- Travel (approximately 35%) domestic and/or international.
- Manages projects in a timely manner in adherence with ICON’s SOP’s, ICH, GCP and appropriate regulation and liaise with other departments as necessary.
- Delivers projects in accordance with the contract, timelines and study budget*
- Identifies out of scope activities and initiates budget change orders and contract amendments
- Attends and presents at Investigator Meetings, Client Kick-Off Meetings, and other client meetings*
- Facilitates the electronic endpoint adjudication system for endpoint adjudication projects
- Ensures all necessary study specific training is provided to study teams to improve performance and knowledge.
- Provides coaching / mentoring as necessary.
- Develops and maintains all trial documentation (ie Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual)
- Performs user acceptance testing of electronic endpoint adjudication system
- Performs data reconciliation
- Serves as the primary study contact for client and internal and external study teams.
- Leads internal and external study team meetings.
- Leads internal DMC and endpoint adjudication processing teams.
- Develops and monitors DMC and endpoint adjudication processing workflows to maintain efficiency
- Prepares meeting agenda and facilitates the completion and distribution of meeting minutes
- Facilitates the development of project reports. Generates and distributes project reports to the study team.
- Coordinates DMC and Endpoint Adjudication Committee members and data review/adjudication processes
- Conducts project/system specific training to committee members
- Implements Quality Control measures for adjudication process and adjudication outcomes as necessary
- Performs project finance reporting activities
- Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues.*
- Participates in interview process for new staff.
- Develops and implements staff training/orientation plans.
- Participates in bid defense and new proposal review activities as necessary
- Participates in internal, client, and regulatory audits
- Participates in the development and implementation of departmental initiatives.
- Other duties as assigned
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- • US/LATAM/CAN: 2 years Clinical Trail Project Manager experience
- • EU/APAC: Prior relevant Clinical Trail Project Manager experience
- • Basic knowledge of applicable global, regional, local clinical research regulatory requirements; ie Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs), or the ability and willingness to gain this knowledge.
- • Prior clinical trial experience
- • Highly developed problem solving skills
- • Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors
- • Excellent computer skills (Microsoft Word, Excel, PowerPoint, Outlook). Experience working with electronic data capture and transfer methods
- • Knowledge of medical terminology
- • Excellent communication and documentation skills
- • Excellent organizational, time management and problem-solving skills
- • Strong sense of responsibility and dedication
- • Attentiveness to detail and accuracy; ability to maintain quality standards
- • Ability to follow instructions/guidelines, utilize initiative and work independently
- • Proven ability to multi-task, manage competing priorities and timelines
- • Ability to manage team members and processes
- • Willingness and aptitude to learn new skills
- • Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees’ location, the employee may be required to possess a valid Drivers license.
- SECTION 4: EDUCATION REQUIREMENTS
- (List requirements in bullet format.)
- • Bachelors Degree or local equivalent in medicine or science
- • Licensed nursing professional or similar medical/scientific certification
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