Project Manager II, IDEA job in

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Senior Project Manager, IDEA

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. This position is primarily responsible for managing all Data Monitoring Committee (DMC) and/or endpoint adjudication processes for multiple clinical trials.

Overview of the Role

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

Role 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.
• 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

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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Project Manager II, IDEA

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