The CDC II is the point of contact for day to day activities on a study with key responsibilities to handle the study independently. Reporting to Group Lead/Manage
Review CRF/eCRF data for completeness, accuracy and consistency via computerized edits and manual data checks.
Generate and close/resolve data queries. Freeze and /or lock eCRFs (as appropriate) within the electronic data capture system.
In accordance with project specific timelines to perform data management activities to ensure the generation of accurate, complete and consistent clinical database.
To train and guide less experienced clinical data coordinators in data management requirements and activities.
Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager (CDL) where needed. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.
Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards
Performs DM activities for start up of a study including preparing the eCRF, CCG's where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT). Manage local lab set up for the Clinical Database as applicable
Performs DM hands on activities during the course of the study. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation. Supports and assists Junior staff for assigned trials
Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence. Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks). Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines
Complete all assigned trainings ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies. Record all billable and non-billable time in the appropriate timesheet management system.
You are:
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Minimum 4 - 6 Years of experience in core DM activities
Ability to work under pressure demonstrating agility through effective and innovative team leadership
Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
Excellent problem-solving skills
Excellent verbal and written skills
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, 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.
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.
