ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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.

Please note that this is a 6-month assignment, extension beyond 6 months is not guaranteed.

• Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution
• Creation of data standards and execution of the clinical data collection strategy in accordance to business standards (Data Collection, SDTM (CDISC)) as applicable
• 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
• 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

You Possess:

• Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals), Mathematics, Computer Sciences or equivalent industry experience.
• Oncology &/or Neurology TA expertise
• 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)
• Proficiency with data management systems such as InForm™, Rave or other industry electronic data capture systems and other systems such as ePRO, eHR, etc.
• Comprehensive knowledge of ICH-GCP and major health authorities (e.g. FDA, EMA, CFDA, PMDA) regulations
• CDISC fundamentals knowledge
• Knowledge of quality assurance
• Proficient Computer Skills e.g. word processing, spreadsheets
• Knowledge of SAS, SQL or other programming languages
• Knowledge of medical terminology, Coding systems, SAE reconciliation

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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