Project Manager I, Idea

Project Manager, Laboratory - Home Based - Mexico City

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

JR122626

Project Manager, Laboratory

Mexico City

Remote (Home 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 organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation 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.

Overview of the Role

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. The Project Manager will ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Laboratory Services (ILS), including the setup and day-to-day management of studies, attend and represent ILS at Client meetings, manage studies in accordance with Good Clinical Practice, provide Clients with regular study updates and communicate study progress to Clients and PM Leadership in a responsible and professional manner, represent Project Management at internal interdepartmental meetings or interdivisional meetings within ICON, help train more junior PMs, act in an advisory role to those less experienced on the team, and work to enhance team tools and practices by actively recommending suggestions for improvements in efficiency, serve as the tactical site supervisor for project manager in the absence of a Team Lead for work related and administrative tasks and take on additional responsibilities to enhance the overall PM Team tools and Practices, as defined by Management.

**Responsibilities**:

- Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
- 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 re