Ecoa Project Manager (Remote)

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

With our patients at the center 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.

RESPONSIBILITIES

Job Detail – Summary:

• Lead the development of Digital Health Operations (DHO) deliverables to meet the needs of the study/program and internal stakeholders.
• Provide technical expertise in Digital Health and specification development, and provide subject matter expertise to cross-functional study teams.
• Lead all DHO-related activities and serve as the main point of contact for the cross-functional study team.
• Maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure the Digital Health Center of Excellence (CoE) processes are at the “best practice” level of performance.
• Support various Digital Health technologies, as needed: eCOA/COA, Imaging, ECG, eConsent, Direct to Patient, Telemedicine, Actigraphy, etc.

Specific Duties:

• Provide advice/recommendation to study teams regarding supplier(s) and technology alternatives.
• Complete Requests for Proposal documentation and recommend appropriate suppliers to support study needs.
• Provide leadership and expertise for the completion of supplier specification development and set-up activities through the lifecycle of a trial.
• Lead the cross functional study team through changes of scope, providing technical expertise on the change of scope, assessment of risk, and oversight of system requirements updates.
• Lead the resolution of issues escalated by study teams under the supervision of Digital Health line management.
• Serve as the point of contact specific to inspection readiness activities between the study team and the Digital Health technology suppliers.
• Effectively manage internal and external business partner relationships in support of R&D Operations’ deliverables.
• Monitor key performance indicators (KPIs) and metrics for services provided by suppliers.
• Conduct Lessons Learned sessions following the completion of study start-up activities and throughout other phases of the clinical development process, as necessary.
• Effectively support the study team in close-out/deactivation of the technology system.

QUALIFICATIONS

• Bachelor’s degree or equivalent education / relevant experience
• 3+ years of operational experience in clinical trials within a pharmaceutical company and/or a CRO
• Expertise working with clinical technologies (eCOA exp. is a must)
• Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning
• Familiarity with industry best practices for vendor management
• Strong project management and presentation skills
• Good understanding of various therapeutic areas (Oncology, Metabolism, Immunology, Infectious Disease & Vaccines, Neuroscience, and/or Pulmonary Hypertension preferred)
• Experience with Digital Health technology suppliers (preferred)

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.