Sr Clinical Project Manager - Home based

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? Education and Skills required:
  • 8 years of relevant experience
  • Minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
  • Reads, writes and speaks fluent English; fluent in language of host country.
Preferred Education and skills:
  • BA/BS or equivalent is preferred with a minimum of 8 years of pharmaceutical or biotech research
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? As a Senior Clinical Project Manager, you will be responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report. They manage the process and people involved though matrix reporting. The position is responsible for coordinating all efforts for the trial both within the Company and through a wide variety of vendors. The role requires active involvement, to meet schedules or resolve problems or conflicts, and entails frequent interaction with subordinates, outside customers, functional peer groups at various management levels and senior management. Gaining project team cooperation, conducting presentations of technical information concerning specific projects and schedules and, solving technical problems, are keys to success. Responsibilities
  • Specific duties are outlined below but are not limited to:
  • Position has overall responsibility to deliver the projects on time and on budget. The CPM drives study conduct to timely completion in compliance with all regulations and SOPs.
  • Responsible for leading clinical trial team meetings. May manage the GDT meeting and perform all required cross-functional follow-up.
  • Cre ates project budgets and manages cost to budgets. Develops enrollment projection, and drug supply needs as part of the budget.
  • Responsible for creating and maintaining MS Project timelines for each project, and uses these timelines to track and manage a project's progress.
  • Reviews study metrics for performance and quality with the team and management.
  • Negotiates and manages competing priorities across multiple functional areas.
  • Manage and coordinate all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the RFP processes and overall budget for each.
  • Prepares high-quality reports (financial, project, etc.) for management on program status and issues.
  • Provide early CPM support (i.e., resource needs, feasibility, protocol writing, etc.) for a study concept until a study CPM is formally assigned to a clinical trial.
  • Provide content for governance meetings on study budgets, timelines, and operational feasibility.
  • Clinical operations counterpart in partner alliance programs.
  • Provide senior level operational review of protocols and other critical documents in the clinical trials.


United States-Remote