Senior Clinical Data Manager-Ecoa

Overview

As a Senior Clinical Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Coordinates CDM process initiatives, including project management, process definition, implementation, change management, and training plans.• Provides regular communications to CDM staff on CDM Operation activities (e.g. process alerts, training updates, changes, and initiative announcements).• Supports the development and revision of CDM processes for both outsourced and in-house stud- ies.• May act as a point of contact and support for CDM staff on key process topics related to data man- agement activities during study startup, conduct, and close out, and working in CDM systems.

• Collaborates with key stakeholders and CDM Operations to support CDM team on setup and man- agement of EDC local lab activities.• Supports the maintenance of the CDM Subject Matter Expert (SME) network for process topics, fa- cilitating timely updates and discussions.• Supports the maintenance and enhancements of departmental Sharepoint sites and trackers, as needed.• Assists in determining role assignment for the Learning Management System (LMS) and associated learning plans.• Supports CDM staff with Quality Assurance related activities such as inspection & audit responses, in collaboration with the CDM Operations Compliance & Quality team.

Qualifications

You are:

• Preferred 6 plus years or equivalent experience in data management and/or drug development pro- cess with expertise in the cross-functional interfaces with the data management function.• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study re- ports) and processes.• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.• Knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; clinical experience in one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neu- roscience, PDT, Rare disease, Vaccines and/or vaccine.• Preferred experience with FDA, EMA or other regulatory inspections of sponsor or CROs• Ability to handle multiple projects simultaneously.• Strong knowledge of data management best practices & technologies as applied to clinical trials.• Advanced knowledge of broad drug development process with expertise in the cross-functional inter- faces with the data management function.• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

eCOA experience

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/benefitsAt 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-accommodationsInterested 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.