Clinical Study Manager II

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

• Human Biological Samples Management Central Team (HBSM CT) 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.
• The Laboratory Study Manager (LSM) within HBSM CT is 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 timely at right quality and cost.
The laboratory network is made from:
o Central laboratories in charge of global laboratory support to clinical studies such as sampling material delivery, sample management, support to testing oversight.
o GSK Laboratories in charge of development, validation, and sample analysis.
o Third Party Laboratories in charge of development, validation, and sample analysis
o Vendors/Laboratories responsible for long-term storage of untested HBS (for future research).

• For a project or a group of studies, ensure effective interface between Central Laboratory (CL) and GSK Project Team, especially the Study

Delivery Lead (SDL), Global Clinical Delivery (GCD), Precision Medicines & Vaccines Clinical Laboratory & Assay Portfolio, Human Genetics, by providing support related to HBSM.
• Have input in study protocol development (mainly clinical laboratory part), CL set up including CL instructions for investigators sites.
• Be main point of contact for the clinical study team and CL.
• Responsible for overview of HBSM in the assigned projects including support investigator sites (mainly based on the cooperation with the Local Delivery Leads (LDLs)) and testing issues in CL.
• Be the HBS custodian for the study, from study start to study end according to the GSK HBSM SOP and related written standards.
• For each study, define the operational set-up to align HBS flows, testing activities and data flows (in cooperation with GSK Data Management) and assure it is in line with the other stakeholder’s constraints.
• Own the HBSM Plan and Samples Risk Assessment process and documents. Ensure that all study related activities are operationally set-up and conducted in line with the approach agreed with the clinical study team.
• Oversight of chain of custody of HBS throughout the lifecycle of the study, including site - central lab and provide consultations for HBSM CT in case of HBSM by Third Party Laboratories.
• 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. Ensure standard processes and ways of working are in place across all project and studies for all key activities of LSMs, e.g., HBS custodian, study set-up with central laboratory, HBSM Plan process, blinding & reconciliation strategy, etc.• First point of CL escalation for the clinical study teams. Understand, mediate and solve complex issues related to LSM 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.
• Ensure alignment in the ways of working for a project or a group of studies.
• 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.
• Manage samples long term storage with input from HBSM CT teams.
• Adhere to the LSM RACI as an integral part of the LSM key responsibilities.
• Able to evolve in a changing and challenging environment, coaches the study team members to focus on value, building business agility and embracing change.
• Excellent networking capabilities and ability to influence and manage stakeholders at all levels of the organization. The ability to facilitate and lead cross functional meetings/challenge status quo and inefficient ways of working and need to be comfortable in a mediation role

Educational Requirements 

• Master’s degree in medical/life sciences or equivalent background.
• Demonstrated expertise in Project Management beyond their own field of expertise.
• Demonstrated capability to integrate complex inter-departmental links, processes, databases, and systems.

• Demonstrated knowledge and competency in laboratory processes and extended knowledge of ICH-GCP/GCLP rules.
• Demonstrated fluency in spoken and written English beyond scientific English.
• Good holistic view especially to proactively detect problems and define possible solution and/or to surface issues to 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.