Project Leader

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.The role:• Project Leader will assist in development and validation of analytical methods to support regulatory studies and manage sample analysis on preclinical and clinical specimens.• Will manage analytical studies to ensure that bioanalysis is well coordinated with the in life study, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period.• Monitor and evaluate the projects progress with respect to milestones, budgets and timelines.• Work with laboratory management to ensure that appropriate resources are available to complete the study to timeline.• Obtain all client specific documents required for the analysis.• Maintain records of work conducted in a timely and consistent manner, sufficient to allow real-time tracking of the deliverables, including tracking of revenue and resources associated with assigned studies.

Main Tasks:

• Ensuring quality control of incorporated transfer specification changes.• Reviewing outgoing study exports for accuracy and completeness.• Conducting quality reviews of incoming clinical data to ensure accuracy and integrity.• Maintaining documentation related to data management.• Implementing and improving quality control procedures to enhance data accuracy.• Investigating and analyzing discrepancies in data to identify and resolve issues.• Overseeing the product delivery software development lifecycle to ensure smooth operation.• Tracking and managing database and product system change control and requests.• Developing and implementing data delivery specification documents tailored to specific study requirements.• Acting as a backup for day-to-day client communication, ensuring continuity of service.• Providing backup support for sending deliverables to clients and key stakeholders.• Assisting in fulfilling client deliverables, including scheduling meetings and meeting submission requirements.• Playing an administrative role in maintaining tracking systems to ensure efficient project management.You will need:• You will possess an Associate’s Degree in relevant biological disciplines/analytical chemistry.• Bachelor’s Degree or equivalent in relevant biological disciplines /analytical chemistry preferred.• A minimum of 5 years’ experience successfully performing a laboratory Scientist role or a minimum of 7 years’ experience of study related matters, GLP or other Quality systems, analytical procedures and general laboratory experience.• Good written record keeping and verbal communication skills.• Ability to accurately follow and communicate precise written and verbal instructionsBenefits 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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