Senior Clinical Data Manager-Ecoa

ICON; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

ICON, the world's largest clinical research organization, is seeking a Senior Clinical Data Manager to lead process initiatives within ongoing clinical trials. This role involves coordinating various data management activities, ensuring compliance with regulations, and supporting CDM staff in their tasks. The ideal candidate will have extensive experience in clinical data management processes, project management skills, and a strong understanding of regulatory frameworks.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

24-hour access to global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• Proven experience managing data management activities for large drug development programs.
• Solid understanding of clinical trial documents.
• Ability to handle multiple projects simultaneously.

Responsibilities

• Coordinate CDM process initiatives and provide regular communications to CDM staff.
• Support development and revision of CDM processes for studies.
• Assist CDM staff with Quality Assurance activities.

Skills

Project Management

Data Management Best Practices

Clinical Trial Processes

GCP Knowledge

Regulatory Compliance

Education

6+ years in data management

Expertise in FDA and ICH Regulations

Job description

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

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.

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/benefits

At 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-accommodations

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.