Project Manager I, IDEA
About the role
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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
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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