Project Manager (Early Development Services)

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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Qualifications

What do you need to have?
  • An undergraduate degree (in health sciences from an accredited institution or internation equivalent degree)
  • Minimum 3 years experience in clinical research, including a management role as a team lead or project manager experience.
  • Phase I experience is preferred.
  • Read, write, and speak fluent English, fluency in the language of the host country required.
To qualify, applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status. Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, 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.

Responsibilities

What will you be doing? The Project Manager (PM) is responsible for owning and achieving interim and final contractual deliverables for assigned projects/programs, according to time, quality/scope and cost constraints. The PM manages the execution of day-to-day work results for projects. The PM leads and directs cross-functional teams, understands and manages client expectations/needs to achieve client satisfaction and ensures adequate internal and external communication of information. The PM proactively identifies, resolves/mitigates and escalates risks and/or issues. The PM adheres to ICH/GCP guidelines, local laws and regulations, and PRA standard procedures and processes. The Senior PM may act as Global or Lead Project Manager in multi-national, multi-site projects/programs. Consequently, the Senior PM may provide oversight to other members of the project management group and may lead special departmental projects/initiatives. In multi-country trials a project manager may be responsible for coordinating country specific study activities only and may report into a global lead PM who acts as primary client contact responsible for achieving contractual deliverables.
  • Acts as primary liaison with client:
    • Acts as lead contact for project matters.
    • Understands/manages/satisfies client contractual, organizational and relationship needs/expectations.
    • Oversees all start-up activities to ensure timely regulatory approval and study start.
    • For NL & PPS Only - Oversees Regulatory timelines, preparation, submission and approval
    • Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client.
    • Chairs and leads customer meetings and documents meeting outcomes.
  • Leads and directs cross-functional team leaders and third parties/vendors with close supervision and support
    • Oversees, coordinates and reviews work produced by project team members per the agreed upon scope of work.
    • Guides and supports team leads in project-specific prioritizing, trouble-shooting and contingency planning.
    • Delegates whilst retaining ownership.
    • Communicates project specific priorities to project team and provides guidance/mentoring as needed.
    • Ensures up-to-date planning information is available to project team and rest of operational organization
    • Chairs internal project team meetings and documents meeting outcomes.
    • Liaises with functional leads/managers to optimize performance and utilization of project team members.
    • Provides feedback on project team member's performance to respective line-managers
  • Manages project contractual deliverables (with close supervision):
    • Monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).
    • Proactively identifies and evaluates alternative solutions to resolve/mitigate and escalate risks and/or issues as appropriate.
  • Manages project costs (with close supervision):
    • Proactively and timely identifies, for assigned projects, ensuring out of scope activities are approved up front via a contract modification.
    • Identifies potential or actual unrecoverable effort and provides analysis and mitigation/resolution plan for senior management's approval.
    • Ensures control of financial risk to PRA.
    • In cooperation with the project analyst, applies efficient management of project pass-through costs and investigator payments for external non-PRA sites to ensure all such costs are recovered in a timely manner, and in advance where ever possible.
    • Leads presentation of financial reviews and is accountable for action item follow up.
  • Ensures that the progress of a clinical trial is conducted and complies in accordance with the protocol, PRA's Standard Operating Procedures (SOPs), ICH/GCP and applicable regulatory requirements at the project level
  • Assumes project leadership role in compliance at project level to PRA processes and systems, including escalation to relevant functional and operational management
  • May participate in and attend the bid defense process
  • Support Business Development department by functioning as point of contact / consultant for clients and Business Development during sales cycle in general and more specifically during the RFP process.
  • May serve as the Operational RFP Lead and take the independent lead in supporting the feasibility, proposal and budget process.


United States-Remote
Canada-Remote
Canada-Remote