Manager, Scientific Affairs - Test Validation

Manager, Scientific Affairs ICON plc is a world-leading healthcare intelligence and clinical research organization.
We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
The role manages, oversees and leads Test Validations, i mplementing new assays across 4 clinical laborat o r i es globally.
This role will support m ultiple platforms and departments including Clinical Chemistry, Hematology, Special Chemistry, Immunology, Pathology, Molecular Biology, and Molecular Diagnostics.
The applicant is not required to be an subject matter expert in all these disciplines but should be knowledgeable enough to communicate across disciplines.
This role a pproves performance of analytical validations within ICON Laboratory Services including the review of assay product inserts, preparation of validation plans, identification and attainment of suitable samples for validation studies, the performance of validation experiments, analysis and quality control of data and the preparation of validation reports.
This pivotal role involves ensuring that all diagnostic tests and procedures meet the highest standards of accuracy, reliability, and compliance.
The ideal candidate will have e xtensive experience in clinical laboratory testing, a strong background in quality assurance, and proven leadership abilities.
This role is office based (hybrid working) at our global HR in Dublin 18.
Key Responsibilities: Lead and manage the validation and verification of diagnostic tests, including new assays and instruments Design, perform, and analyse Accuracy, P recision, Reference Range, AMR and other standard validation / verification experiment s Manage the validation of complex and Lab Developed tests including modifi cations to existing tests .
Work directly with Sponsors on Sponsor - specific validations and requirements Ensure that all validation processes comply with regulatory requirements, industry standards, and internal quality guidelines while following and maintaining Global SOPs .
Conduct regular assessments of validation practices to identify areas for improvement.
Perform root cause analysis on quality issues and suggest corrective and preventive actions.
Supervise and mentor a team of Global V alidation Analysts Provide training and support to team members on validation techniques and best practices.
Foster a collaborative and high-performance work environment.
Identify and implement training programs as necessary to ensure they receive training in supervisory skill development Productively work with internal groups such as Regulatory Affairs, Medical Affairs, Clinical Research, Project Management, and/or Quality Assurance to ensure efficient operations across the organization Work closely with cross-functional teams including Laboratory operations, Global Q uality C ontrol, and R egulatory A ffairs.
Liaise with global laboratories to coordinate validation activities and share best practices.
Keep management informed of project status in relation to quality and timelines using the validations tracker .
Independently provides additional medical communications writing and editing services as required (for example for manuscripts, abstracts and scientific posters).
Stay current with changes in regulatory requirements and ensure that validation processes are updated accordingly.
Prepare and present documentation for regulatory submissions and inspections in collaboration with Regulatory Affairs .
Maintain accurate and thorough documentation of all validation activities.
Prepare comprehensive reports for internal stakeholders and regulatory bodies.
Exhibit excellent written and oral communication and presentation skills.
Is able to collaborate well at a complex level.
What you need: Education: Bachelor's degree in Clinical Laboratory Science , Biomedical Science, or a related field; advanced degree preferred.
Minimum of 10 years of experience in clinical laboratory testing, with at least 3 years in a management or leadership role focused on test validations.
Experience in EP evaluator software , preferable Strong knowledge of validation methodologies, quality assurance principles, and regulatory requirements (e.g., CAP, NYS, CLSI, FDA, ISO, CLIA).
Excellent leadership and team management skills.
Proficiency in data analysis and interpretation.
Exceptional communication and interpersonal skills.
Ability to work effectively in a global and cross-functional environment.
#LI-SB2 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, diversity, inclusion & belonging are fundamental to our culture and values.
Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.
We're proud of our diverse workforce and the work we've done to become a more inclusive organisation.
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.
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