Non-Interventional Study Research Manager

About the role

Non-Interventional Study Research Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Non-Interventional Study Research Manager at ICON, you will manage clinical trial operations activities, supporting your team and stakeholders to deliver high-quality outcomes across our clinical programs

What You Will Do:

Under the supervision of the Associate Director, you will lead operational activities related to study planning, study execution, and the summarization of results from observational research studies and related activities. Key responsibilities include:

• Coordinates the end-to-end process for executing observational or non-interventional research studies, in compliance with Good Pharmacoepidemiology Practice (GPP) and CORE Standard Operating Procedures (SOPs).
• Plans, initiates, executes, and closes out primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities (e.g., literature reviews, dossier development, economic modelling support, etc.)    
• Collaborates with colleagues across CORE, Global Medical and Scientific Affairs (GMSA) to support the lead scientists (from GMSA) in overall operational support for study conduct.
• Provides study-level management support, which includes facilitation of the execution of appropriate service for approved proposals/scopes of work (including the review of requests for information/proposal, draft scope of work, where applicable), confidentiality and consultant agreements, and subsequent amendments/change orders.
• Participates in protocol and interim/final report preparation and literature review abstraction and summarization.   
• Coordinates the review and finalization of all vendor documents, such as the safety management, data management, communication, project management, and validation plans  Tracks study timelines and deliverables and follows up on action items.
• Collaborates extensively and troubleshoots issues by providing potential resolutions (when necessary) with internal and external partners, ensuring timely study management and execution  Assists in tracking study milestones and timelines.
• Liaises with outsourced vendors and cross-functional teams to communicate and oversee project status and/or needs.
• Participates in quality control assessments and ensures integrity of study data for reports and publications.
•  Understands, coordinates, and documents adherence to internal, external, and regulatory compliance requirements.
•  Utilizes, manages, and maintains document repositories and internal/external systems (e.g., REV OPS, Engage Zone, Veeva Vault).  
• Provides operational support for due diligence checks, site contract and budget review/approval, informed consent, study registration, IT and/or privacy assessments, vendor qualification, adverse event reporting and reconciliation, and publication submissions.
• Manages poster and publication development, including formatting, medical writing, figure/data content development, co- author review, internal review process

Your Profile:

• Two or more years of work experience within clinical/observational research or equivalent experience.
• Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholder.
• Basic knowledge of epidemiologic or outcomes research.
• Fluency in English (written and spoken)
• Strong project management and prioritization skills.
• High level of motivation and ability to work independently and collaboratively.

Required qualifications and experience:

• University degree in medicine, science, or equivalent combination of education & experience
• Demonstrated ability to drive the clinical deliverables of a study
• Subject matter expertise in the designated therapeutic area
• Prior monitoring experience is preferred
• Willingness to travel as required (approximately 25%)

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply

2+ years clinical/observational research experience; university degree in medicine or science; basic epidemiology knowledge; English fluency; project management skills; willingness to travel ~25%.

Key Responsibilities

• managing study operations
• coordinating vendors
• tracking timelines

Skills & Tools

REV OPS, Engage Zone, Veeva Vault

Job Details

• Category: Project and Program Management
• Seniority: Mid Level
• Commitment: Full Time
• Workplace: Remote — Blue Bell, Pennsylvania, United States
• Languages: English

Benefits

• Generous paid time off
• Retirement plan

About ICON plc

A global provider of outsourced clinical research and development services. — Industry: Research and Development