Associate Director, Clinical Data Manager
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
Associate Director, Clinical Data Manager (Sponsor Dedicated)
Fixed Term - 6 months
What You Will Be Doing:
* Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity.
* Is recognized as an expert within the discipline and beyond, with peers within the same technical area in the business as well as other key business functions.
* Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution
* Serves as best practice resource within own discipline or as technical expert on cross functional teams or projects.
* Has in-depth organizational and relevant market knowledge and uses understanding on how relevant areas can be integrated to achieve objectives.
* Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
* Project management of all clinical data management related deliverables including operationalization by steering internal and external experts and specialist. Ensuring adherence to planned time, cost and quality
* Execution of the clinical data collection strategy in accordance to Sponsor Standards.
* Accountable for oversight of CROs in the execution of Phase I – IV clinical trial(s).
* Represents Data Management within the Global Trial Team and serves as the key Global Development Operations point of contact for the DM related tasks in a trial/project/program
* Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams.
* Drives, leads and manages the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills.
* Ensures strong oversight, review and delivery of trial/project DM related CAPAs in order to meet corporate compliance standards and timelines.
* Accountable for partnering with CRO in DM related audit responses and addressing quality issues.
* Provides leadership and contributes to all operational aspects of the DM related trial budget, including forecasts to ensure delivery within the R&D financial standards.
* Performs review and provides strong operational input in the development of Clinical Trial Protocols, Integrated Analyses Plan and CSRs
* Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
* Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
Your Profile:
* Advanced degree in Data Science, Statistics, Bioinformatics, or a related field.
* Experience in all aspects of Data Management related clinical study planning and execution, and in executing the complete range of clinical study activities, from concept sheet through final study report and archiving.
* Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to at least 10 years.
* Substantial project management experience.
* Strong leadership competencies and influencing skills.
* Effective oral and written communication skills
* Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
* Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)
* Successful completion of multiple studies from beginning to end providing a full scope of DM experience .
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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 maximize 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 site to read more about the benefits ICON offers.
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, 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 or submit a request here.
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.
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