Clinical Study Manager II

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

ob Purpose: 

You will be part of the Human Biological Samples Management (HBSM) team that support Clinical Trials involving Human Biological Samples (HBS) that are collected, stored, transferred, analyzed, and destroyed as part of the clinical trial. The management of the HBS and associated laboratory activities need to be coordinated in a manner that ensures compliance (ethical, legal, and regulatory) and quality to appropriate standards.

In this role you will be responsible for the operational set-up & follow-up of central laboratory (CL) related activities for a project or a group of studies to guarantee alignment amongst the entire network and with Clinical Operations to support delivery of laboratory results.

Responsibilities:

You will be responsible for a project or a group of studies, ensure effective interface between Central Laboratory (CL) and a Clinical Study Project ManagementTeam, Precision Medicines & Vaccines Clinical Laboratory & Assay Portfolio, Human Genetics, by providing support related to Human Biological Samples Management (HBSM).
Input in study protocol development (mainly clinical laboratory part), Central Laboratory (CL) set up including CL instructions for investigators sites.
Be main point of contact for the clinical study team and Central Laboratory.
Responsible for overview of Human Biological Samples Management in the assigned projects including support investigator sites (mainly based on the cooperation with the Local Study Managers) and testing issues in Central Laboratory
Oversight of chain of custody of Human Biological Samples throughout the lifecycle of the study, including site - central lab and provide consultations for HBSM team
Follow up on study KPIs, identify trends and ensure problems with HBSM are addressed.
Act as Subject Matter Expert (SME) for one or several processes of the team.
First point of Central Laboratory escalation for the clinical study teams. Understand, mediate and solve complex issues related to deliverables and escalate as required.
Monitor study related activities to provide management with consolidated information on central laboratory, sample management, data delivery, CL budget review & annual forecast as well as key performance indicators to surface HBSM issues.
Support external and internal project audits in CL/HBSM part.
Support CL database reconciliation with all CL related issues based on the strong cooperation with assigned Data Manager.

• Requirements:

  Master’s degree in medical/life sciences or equivalent background.

  5 years of operational experience in clinical laboratory activities and clinical study conduct

  Demonstrated knowledge and competency in laboratory processes and extended knowledge of ICH-GCP/GCLP rules.

  Proven experience in clinical project planning, project management and issues resolution 

  Ability to quickly integrate with clinical development processes and global network to build strong partnership with lab vendors and pharmaceutical stakeholders.

  Experience of managing business remote matrix network of internal and external stakeholders of multicultural and multidisciplinary people with different expertise and various scientific background

  Fluency in spoken and written English beyond scientific English.

  Expertise in Project Management

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.