Job Title: Senior Clinical Data Science Lead
Location: United States (Remote)
About ICON plc: ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.
Responsibilities:
Coordinate CDM process initiatives, including project management, process definition, implementation, change management, and training plans.
Provide regular communications to CDM staff on CDM Operation activities (e.g., process alerts, training updates, changes, and initiative announcements).
Support the development and revision of CDM processes for both outsourced and in-house studies.
Act as a point of contact and support for CDM staff on key process topics related to data management activities during study startup, conduct, and closeout.
Collaborate with key stakeholders and CDM Operations to support the CDM team on setup and management of EDC local lab activities.
Support the maintenance of the CDM Subject Matter Expert (SME) network for process topics, facilitating timely updates and discussions.
Support the maintenance and enhancements of departmental Sharepoint sites and trackers.
Assist in determining role assignments for the Learning Management System (LMS) and associated learning plans.
Support CDM staff with Quality Assurance activities such as inspection and audit responses, in collaboration with the CDM Operations Compliance & Quality team.
Qualifications:
Preferred 6+ years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) 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 therapeutic areas such as cell therapy, oncology, GI, neuroscience, 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 the broad drug development process with expertise in the cross-functional interfaces with the data management function.
Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
What ICON can offer you:
Competitive salary and benefits focused on well-being and work-life balance.
Various annual leave entitlements and health insurance options for you and your family.
Competitive retirement planning offerings to maximize savings for the future.
Access to the Global Employee Assistance Programme (TELUS Health), offering 24-hour support.
Life assurance and flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, and discounted gym memberships.
At ICON, inclusion & belonging are fundamental to our culture and values. We are committed to providing an environment free from discrimination and harassment.
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