Senior Scientific Affairs Specialist - Protocol Review

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Position: Senior Scientific Affairs Specialist

Location: On-Site in Farmingdale, N

About Us:

At ICON Lab and Imaging Solutions (ILI), we are dedicated exclusively to central laboratory testing and associated services for clinical trials. We are seeking a skilled and experienced Senior Scientific Affairs Specialist to join our team and play a key role in delivering consistent and high-quality scientific support for global clinical studies.

Overview:

As a Senior Scientific Affairs Specialist, you will be responsible for assisting in the delivery and monitoring of consistent deliverables for Global Scientific Affairs. You will take the lead on Scientific Affairs requests and issues, collaborating with other ILI departments to find solutions to testing requests. Your role will involve updating specimen requirements, stability, and transport information within departmental databases using various resources such as the internet, journals, and internal validation documentation.

Responsibilities:

• Assign and delegate work from the Scientific Affairs In-box, ensuring all Service Level Agreements for Turnaround Time (TAT) are met.

• Manage and contribute to the training of new employees and cross-training of Global Scientific Affairs staff on Scientific Affairs tasks.

• Review proposals and protocols for required tests and technical information for new tests, seeking clarification when necessary.

• Follow up on post-award issues and ensure the completion of the full Global Scientific Affairs processes.

• Attend meetings with internal and external clients on behalf of Global Scientific Affairs.

• Lead efforts for studies involving Anatomical Pathology testing, from study set-up to data transfers.

• Assist with referral lab identification and maintenance.

• Coordinate and generate performance metrics for Global Scientific Affairs’ deliverables.

• Assist in obtaining technical information for new assays and package inserts from internal resources for in-house assay validation efforts.

• Liaise with Quality Assurance and Client Services for inventory management and special collection instructions.

• Follow SOPs relevant to Global Scientific Affairs issues.

• Provide notifications and technical documentation to the Global Validation Department and Global Client Services.

• Maintain CLSI documents library.

• Perform additional responsibilities as requested by management.

• Exemplify ICON's values of commitment to People, Clients, and Performance.

Requirements:

• Bachelor's degree in Medical Technology or equivalent.

• Minimum of 7 years of relevant experience.

• Knowledge of clinical laboratory concepts and terminology.

• Proficiency in MS Word and Excel.

• Customer-focused mindset with the ability to provide timely, confident, reliable, and friendly service to internal and external customers.

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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.

#LI-MM2