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:...growth of our business across California, working closely with the company President and Corporate team. Advising on a wide range of legal matters, including regulatory, operational, and employment issues to support the companys growth and business strategy. in...
...shapes the role. This position is 100% Remote. Will look at entry level experience with good Excel skills. Responsibilities: ... ...Collect, organize, and clean data from various sources, including Salesforce, Mailchimp, and Filevine. Compare datasets in...
...Talent Acquisition Representative: Nicole Coult Sponsorship Available: No Relocation Assistance Available: Yes Senior Director Global Security & Investigations The Sr Director of Global Security and Investigations is a pivotal leadership role responsible for the...
...enhances our ability to succeed and grow. Division Description The California Housing Finance Agency (CalHFA) Information Technology (IT) Division is responsible for providing secure, responsive, and innovative technical infrastructure, systems, and services that...
...develop customized menus that cater to their specific tastes, dietary requirements (including allergies and specialized diets like vegan, gluten-free, keto, etc.), and health goals. Source the finest ingredients: Utilize your expertise to select and procure the freshest...