Senior Manager, Clinical Data Management
PH-Manila
PRA Health Sciences
Req #: 117610
Type: Philippines
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Overview: Location: Philippines (Homebased) Under the direction of the Data Management Lead, the Senior Manager Clinical Data Management is responsible for timely and high-quality data management deliverables supporting the company's portfolio. They are responsible for conducting oversight of Data Management activities at the project or program level - as performed within the company or by Strategic Partners, CROs or other 3rd Party Vendors - to ensure they meet obligations as described in ICH-GCP and company's Scope of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides and enables solutions for complex problem solving that align with the company values. The Senior Manager Clinical Data Management serves as an expert for clinical data management. They will lead cross-functional team members to perform proper Data Reviews and provides guidance on CDISC standards. Responsibilities: What You Will Be Doing: * Under the direction of the DM Lead, responsible for leading data management activities for in-house and outsourced studies; * Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and the company for all data related deliverables, especially in support of key decision points and regulatory submissions. * Contributes influential leadership in collaboration with other Stakeholders 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. * Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams. * For studies where data management activities are conducted within the company, leads and manages clinical trial data collection set-up, data review, and database lock: * Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. * 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. * Leads data review, including query management, and leads activities required for interim and final database locks. * May oversee above activities at the program level. * Participates in preparing function for submission readiness. * Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. * Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. * 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. * Acts as a process expert for operational and oversight models. * May prepare metrics to support the function's KPIs. * Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are 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: Your Profile: * BS/BA required preferably in a health-related, life science area or technology-related fields. * Preferred 6 plus years of 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. * Experience with all phases of development in one or more therapeutic areas preferred. * Ability to handle multiple development programs simultaneously. * 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. * Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. * Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function. * Experience with budget planning & management. * Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings. 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. 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.
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