As a Study Delivery Specialist, you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. You will provide support to the clinical trial team at the global level impacting directly the project's success.
What you will be doing:
Keeping up to date with all the changes/required knowledge on ICH GCP, sponsor's written standards and attending appropriate training sessions.
May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.
Management of access and study trackers:
Maintain all the study trackers and access.
Analysis of various reports.
Timely distribution of dashboards and reports to the study team.
System related support:
Managing study systems.
TMF Management and Maintenance.
Managing TMF activities both for In-house and FSO trials.
Provide timely follow up with the stakeholders to improve the TMF compliance.
General areas:
Common email group to support the issues related to CSAP, CTMS.
Clinical admin support.
Support to studies where there is no requirement of SDS Archival support.
Work closely with SDS/SM to manage the activities post SAC and till final archival.
You are:
Excellent technical/IT skills. Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of sponsor's systems/software.
Knowledge of ICH GCP relevant operational procedures, systems, and quality guidelines regarding clinical studies.
Able to work independently as well as in a team.
Professional attitude with good customer focus (internal and external).
Time Management as system updates, eTMF etc. need to be done in a timely manner.
Very good communication skills - high English level.
1-2 years of prior experience in clinical operations as CTA, CPA or similar.
Knowledgeable of main systems (vTMF, mCTMS) and the willingness and ability to continuously learn and become highly competent in using sponsor's evolving systems and tech.
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 maximize 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 specialized 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, subsidized travel passes, health assessments, among others.
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 organization. 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.
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.
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