Project Manager I, IDEA

Project Manager, IDEA - Remote, US

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Position Summary:

This position is primarily responsible for managing all Data Monitoring Committee (DMC) and/or endpoint adjudication processes for a clinical trial.

Job Functions/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) 
• 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 team.
• 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 process
• 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 bid defense and new proposal review activities as necessary
• Participates in internal, client, and regulatory audits
• Other duties as assigned

Requirements:

​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.

• A 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

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.  All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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