Title: Project Manager, IDEA
Location: Remote (US-Based)
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
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
- Excellent communication and documentation skills
- Excellent organizational, time management and problem-solving skillsStrong 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.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and 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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
