SMA I
- Bulgaria, Hungary, Romania
- Laboratory
- ICON Strategic Solutions
TA Business Partner
- Icon Strategic Solutions
About the role
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As a Laboratory Study Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
The Laboratory Study Associate (LSA) within HBSM Central Team works in close collaboration with the Laboratory Study Manager(s) (LSMs), the Central Laboratories Oversight team and Cell Mediated Immunity (CMI) Network Laboratories team, providing operational and administrative support for the delivery of the project and study laboratory activities, in adherence with controlled documents. The LSA also supports the overall management of the laboratory study budget
Key Responsibilities:
- Provide support in the set-up of specific meetings with internal as well as external stakeholders (e.g., Operational Excellence Committee (OEC)-meetings with Third Parties, Operational meetings with Third Parties).
- Creation, review, maintenance and tracking of clinical trial documentation related to lab activities.
- Support the collection and storage of study specific documents that are required for the electronic Trial Master File (eTMF).
- Support the creation of Monitor’s Meetings presentation in collaboration with the LSM.
- Ensure set-up and maintenance of study related databases and tracking tools as required throughout the trial.
- Providing support in the set-up and pro-active follow-up of operational laboratory related activities (e.g. status on lab supplies, sample tracking).
- Ensuring quality check / double-check on specific procedures.
- Provide support to the study budget follow-up (e.g. Introduce shopping cart request, check central laboratory invoices versus study price list and actual service done, ask for credit note, highlight issues related to actual budget versus PO amount to Lab Study Manager).
- Co-ordinate all study archiving activities.
- Assistance in the preparation and support of audits and inspections.
- Act as Quality & EHS coach for team staff, including monitoring of external partners.
- Ensure appropriate documentation and tracking of Quality & EHS related activities.
Requirements
- Graduate Degree in life sciences or equivalent experience
- Ability to work within teams and networks across functional and geographical boundaries
- Time management skills, ability to set and manage priorities and multiple tasks
- Fluent in speaking and writing in English
- Excellent communication skills
- Eye for details
- Able to evolve and in a changing and challenging environment.
- Stress resistant
- Positive team spirit and interpersonal skills
- Solid expertise in laboratory operations and quality systems
- Familiarity with basic finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports.
- Excellent computer skills (Microsoft Office (Excel, Word, PowerPoint), SAP)
- Knowledge of ICH/GCP
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, inclusion & belonging are fundamental to our culture and values. 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, 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 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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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