Clinical Data Manager

Overview

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

Responsibilities

What you will be doing:

* Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. * Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.* Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.* For studies where data management activities are conducted within Takeda, leads and manages clinical trial data collection set-up, data review, and database lock:(a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA.(b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.(c) Leads data review, including query management, and leads activities required for interim and final database locks.* Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.* Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.* Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.* Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.* May prepare metrics to support the function’s KPIs.* Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Takeda.* Contributes to functional Continuous Improvement initiatives, providing expertise and ensuring deliverables are provided on time, to budget, and in alignment with company, departmental or functional requirements.* Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables * Champions and adopts technology improvements and tools for use in clinical data management processes.* Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.* Performs other duties as assigned.

Qualifications

You are:

Educational Qualifications* BS/BA required preferably in a health-related, life science area or technology-related fields.Experience* Preferred 4 plus years or experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.* Proven track record of strong project management skills and experience managing data management activities for large drug development programs.* NDA/CTD Experience preferred.* Strong knowledge of data management best practices & technologies as applied to clinical trials.* Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.* Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process

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/benefitsAt 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-accommodationsInterested 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.