Clinical Team Operations Leadership - Home Based (US or Canada)

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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 you need to have:
  • Minimum of a bachelor's Degree or equivalent work experience is required, Post-Graduate degree in Project Management or business is preferred.
  • Professional Project Management certification is preferred
  • Minimum of 5 years industry/CRO/business experience is required in clinical drug developmentand/or clinical operations, clinical R&D experience preferred.
  • Minimum of 3 or more years' experience in Project Management is preferred.
  • Prior experience leading a cross-functional global teams is required
  • Demonstrated ability to resolve conflict and influence teams without direct authority.
  • Successful experience in planning and management of governance
  • Proficient in MS Project is required
  • To qualify, applicants must be legally authorized to work in the Canada or US, 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

This position will primarily support the Global Program Leaders (GPLs) in management of a Clinical Team to meet the agreed upon deliverables as outlined in the Compound Development Plan (CDP). Services include understanding the drug development process to deliver a clinical program according to quality, timelines, and budget in close partnership with the GPL, as well as with the Clinical leader and the project Management Lead (PML) responsible at the Clinical Development Team (CDT) level. Services include managing external partners and non-vendor relationships, managing stage gate activities for the TA governance (such as writing memos and facilitating meetings), liaise with responsible for functions clinical supplies needed for the program, addressing Urgent Safety Measures for the team, and providing support for financial and timeline planning. What you will be doing:
  • Manage Clinical Team (CT) agendas, information, documentation, and team communications toensure timely and accurate dissemination of the CT strategy and operational status throughout the cross-functional team and between co-development partners and/or other external partners as applicable. Ensure documentation of team meetings, key decisions, action items, risk, and team communication.
  • Partner with the GPL and GTL, as well as the program Coordinators and Finance to supportcontinuous forecast for the program under that Clinical Team.
  • Partner with cross-functional leads for the program within Global Development and outside of Global Development such as regulatory, finance, clinical supplies, Biomarker depts and Global Medical safety to ensure appropriate communication and escalations and resolutions around risks and issues are being shared when it comes to quality, timelines, and budget.
  • Manage the governance infrastructure and reporting with co-development partners and or other external partners as directed by the GPL.
  • Manage clinical team governance deliverables partnering with the GTLs for trial level information


United States-Remote