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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 organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation 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.

Responsibilities:

Adherence to ICON Values:

• Recognize, exemplify, and adhere to ICON's values, focusing on commitment to People, Clients, and Performance.

Process Improvement:

• Embrace and contribute to a culture of process improvement, streamlining processes to add value to the business and meet client needs.

Travel:

• Travel domestically and/or internationally as needed (approximately 1%).

Project Monitoring and Evaluation:

• Monitor and evaluate CMC project progress in terms of milestones, budgets, and timelines.

Study Management:

• Manage CMC projects to ensure coordination with in-life project phases and proper activity tracking throughout the study duration.

• Work with laboratory management to ensure adequate resources are available for timely completion of studies.

Client Communication:

• Obtain all client-specific documents required for analysis and review protocols and amendments for adherence to specifications and regulatory requirements.

• Prepare analysis plans tailored to client needs and obtain client approval.

• Provide regular updates to sponsors, forecasting study progress, and reporting any significant deviations.

Project Delivery and Reporting:

• Ensure project delivery, reporting specifics, and timelines are met as agreed upon.

• Maintain records of work conducted, tracking revenue and resources associated with assigned studies.

• Identify changes to the scope of work and ensure proper processing of change orders.

Data Review and Compliance:

• Review and approve all data in accordance with direction documents, ensuring compliance with GMP regulations and SOPs.

• Initiate investigations and event deviations as necessary and address QA findings in reports.

Documentation and Archiving:

• Prepare reports of work conducted, address all QA findings, and ensure proper archiving of documentation upon study completion.

• Review and approve laboratory notebooks and analytical data as required.

Regulatory Compliance:

• Work in compliance with GMP/GCP standards and maintain awareness of current SOPs.

Other Duties:

• Perform any other duties related to maintaining the provision of CMC Services.

Qualifications:

• A minimum of 3 years' experience in a laboratory or project management role, at the discretion of the hiring manager.

• Strong background in project management, preferably in a bioanalytical or pharmaceutical setting.

• Familiarity with GMP regulations and compliance requirements.

• Excellent communication and interpersonal skills.

• Ability to effectively manage resources and prioritize tasks to meet project deadlines.

• Detail-oriented with strong organizational and problem-solving abilities.

• Bachelor's or Master's degree in a relevant scientific field preferred.

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.

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