Job Description
As an Associate Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing: • Managing the day to day assigned study responsibilities as delegated by the Clin Ops Lead to ensure deliverables are met in all phases of trial. This includes but is not limited to:
• Managing small studies at various points in the trial lifecycle, managing regions or countries within a larger clinical trial, managing vendors or activities across multiple trials.
• Deputizing for Clin Ops Lead, as needed.
• Contributing to development of study documents (protocol, consent forms, clinical study plans, etc.), including drafting updates and managing reviews.
• Assisting team with clinical development strategy, budget, and plan and manage study-level timelines with oversight from Clin Ops Lead.
• Managing and overseeing assigned CRO activities and/or subcontracted vendors activities, under oversight from Clin Ops Lead.
• Participating in clinical review of CRFs, CRF completion guidelines, and data review.
• Participating in clinical system build and test efforts (EDC, IRT, etc.).
• Assisting in identification and selection of clinical sites, including feasibility process.
• Assisting in monitoring and managing budgets and contracts for clinical sites.
• Providing input and coordinating delivery of IP to sites in collaboration with Clinical Supply team.
• Collaborating and supporting Clin Ops Lead and/or Program Clin Ops Lead to perform key tasks within the clinical trial process such as monitoring oversight, managing clinical trial insurance, deviation processes and clinical quality metrics.
• Supporting maintenance of trial metrics, including routine reporting as assigned.
• May perform some Clinical Trial Associate tasks if required, including mentoring of new CTAs.
• Supporting team with submissions to IRB/IEC and regulatory authorities.
• Liaising and coordinating document upload and QC checks with TMF team.
• Ensuring assigned trial or part of trial is conducted in accordance with client and ICH/GCP standards.
You are: • At least 2 years of trial coordination experience in a clinical research and industry environment with up to 5 years’ experience in a clinical research and industry environment.
• Advanced degree preferred or Bachelor’s in a science-based subject.
• Relevant experience in global setting.
• Solid understanding of drug development.
• Good project management skills.
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
• Excellent verbal and written communication skills.
• Good organizational skills and attention to detail.
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:
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.
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.
Job Tags
Remote job, Permanent employment, Self employment, Flexible hours,