Sr. Clinical Trial Manager-Early Development-Endocrinology/Peptides/Rare Disease (US Remote)

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.

The Sr. Clinical Trial Manager (Sponsor dedicated FSP) is responsible for the execution of the assigned clinical study(ies), from initiation through closeout.  The Sr. Clinical Trial Manager leads the cross-functional study team in the development and execution of clinical trials and is accountable to deliver trial(s) with quality, on time, and within scope and budget. The Sr. CTM leverages project management, operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive and coordinate efforts to achieve or exceed trial deliverables.

• Manage and coordinate efforts of cross functional project teams to support milestones and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. 
• Develop study management plans, together with team assignments and accountabilities and oversight of external Third-Party Organizations (TPO).
• Manage TPO qualification process and selection.
• Serve as primary project contact with TPO to manage relationships and ensure communication is maintained, continuously improved, and reporting schedules are adhered to.
• Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk.
• Identify quality issues with the study through regular review of site communications, monitoring visit reports, data information, and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
• Collaborate with other functional groups where necessary to support milestone achievements and to manage study issues and obstacles.
• Implement continuous improvement activities for assigned project.
• Provide input for the development of proposals for TPO work and budgets.
• Review and approve vendor invoices in collaboration with the Accounting team to ensure payments occur in a timely manner.
• Prepare and present project information at internal and external meetings.
• Partner with TPO to coordinate and actively participate in site and investigator training.
• Accountable for trial enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).
• Responsible for ensuring a state of inspection readiness of the TMF records that are created, maintained, and finalized. May participate in site inspections or sponsor regulatory inspections.

Minimum Required Education and Experience

• Bachelor’s Degree in life sciences or related field and 5-year clinical research experience in Phase I -3, including 4 years project management experience, or equivalent combination of education, training, and experience.

Required Knowledge, Skills and Abilities

• Demonstrated understanding of drug development process.
• In depth knowledge and skill in applying applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Demonstrated ability to lead and influence cross-functional team members and TPOs on aspects of the clinical trial process.
• Proficiency in use of project management tools and techniques (e.g., MS Project, MS, Excel, MS Powerpoint)
• Ability to travel periodically

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.