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Associate Director, Clinical Data Manager (Sponsor Dedicated). 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.
Job Responsibility:
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
Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution
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
Requirements:
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
What we offer:
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others