Project Manager I, IDEA

This position is primarily responsible for managing all Data Monitoring Committee (DMC)/Data Safety Monitoring Board (DSMB) processes for a clinical trial.

Job Responsibilities

* 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 project 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 the endpoint adjudication project
* Ensures all necessary study specific training is provided to study team to improve performance and knowledge. Provides coaching I mentoring as necessary.
* Develops and maintains all trial documentation (i.e. Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual)
* Serves as the primary study contact for client and internal and external study teams.
* Leads internal and external study team meetings.
* Leads internal DMC team.
* Develops and monitors DMC 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 committee members and data review process
* Conducts project/system specific training to committee members
* Performs project finance reporting activities
* Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues.
* Participates in bid defense and new proposal review activities as necessary
* Participates in internal, client, and regulatory audits
* Other duties as assigned

Requirements

• Bachelors Degree or local equivalent in medicine or science
• Minimum of 1 year of relevant clinical research industry 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.
• 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