Bioanalytical Operations Manager

As a Bioanalytical Operations Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Clinical Bioanalytical Operations Manager is an operational role within the BioSample Operations group in Global Clinical Operations to enable operational processes and the delivery of clinical bioanalytical data from Contract Research Organization (CRO) to support clinical development programs.

As an integral member of a team, the Clinical Bioanalytical Monitor will be working closely with other clinical study team members to perform a diverse range of operational activities, which directly impacts thesuccess of the clinical programs he/she supports.

What you will be doing:

• Represents BioSample Operations group on multiple clinical study teams. Responsible for addressing clinical study teams’ requests related to Pharmacokinetic (PK) and immunogenicity data either directly or via coordination with other clinical study team members, particularly the project representative and clinical pharmacologist.
• Oversees clinical PK and immunogenicity sample flow and data transfer process.
• Support contracting activities with bioanalytical CROs including execution of contracts and change orders, organizing and filing all contract documents.
• Support budget planning for outsourced studies.
• Support publication of bioanalytical study reports in the regulated database.
• Facilitate document filing related to inspection readiness.
• Accountable for ensuring CRO oversight activities related to outsourced bioanalytical studies are performed according to the agreed timelines and quality and in compliance with current guidelines andinternal standards.
• Organize meetings and write meeting minutes.

You are:

• PhD, Master’s, or bachelor’s degree in biomedical sciences or related fields with 0-3 years (for PhD candidates) and 3-5 years (for candidates with Master’s degree), and 6+ years (for candidates withbachelor’s degree) of post-graduate experience in the life sciences industry.
• Experience in NBE and/or NCE bioanalysis and bioanalytical assay development are highly desirable
• Technical experience with Ligand Binding Assay, Cell-Based Assay, and LC-MS is desirable
• Experience related to clinical study management is a plus
• Experience working with a CRO or external partner is desired
• Working experience in GLP or GCP regulated environment is an advantage
• Good understanding of drug development and discovery processes is desirable
• Prior project coordination and/or project management experience is desired
• Excellent self-organizational and time management skills are required. Attention to detail is essential
• Strong computer skills with Microsoft Excel, Powerpoint, and Word are required
• Proficient in communication with impact
• Fluent spoken and written English
• Good intercultural understanding

Why ICON?Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, 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, colour, 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.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.