Job Title: Senior Manager, Clinical Data Management
Location: Philippines (Homebased)
About ICON plc: ICON plc is a leading healthcare intelligence and clinical research organization. We support pharmaceutical, biotechnology, medical device, and government organizations, driving the development of drugs and devices that improve quality of life. Our people form the core of our culture and success, working together to ensure we advance clinical research and make a significant impact.
Responsibilities:
Under the direction of the Data Management Lead, lead data management activities for both in-house and outsourced studies.
Oversee vendor activities across global development programs, representing the data management function on the Clinical Sub-team to ensure aligned expectations for all data-related deliverables.
Collaborate with stakeholders and CRO partners to resolve issues, mitigate risks, and meet key decision points and regulatory submissions.
Lead clinical trial data collection set-up, data review, and database lock when data management activities are conducted internally.
Work with cross-functional teams to set up EDC and other study data collection tools such as IRT, ePRO, and eCOA.
Create and maintain study data cleaning plans, including edit checks, data integration specifications, and external data reconciliation plans.
Lead query management and activities for interim and final database locks, overseeing these activities at the program level as needed.
Ensure submission readiness and archival of all Data Management Trial Master File (TMF) documents.
Plan and manage external Data Management budgets and timelines, providing updates on variances and supporting continuous improvement in forecasting.
Act as a process expert for operational and oversight models, contributing to functional Continuous Improvement initiatives.
Champion and adopt new technologies and tools for clinical data management processes.
Qualifications:
BS/BA required, preferably in a health-related, life science, or technology-related field.
Minimum of 6 years of experience in data management and/or drug development, with expertise in cross-functional interfaces.
Proven track record of managing data management activities for large drug development programs.
Experience with all phases of development in one or more therapeutic areas.
Strong knowledge of data management best practices and technologies in clinical trials.
In-depth understanding of clinical trial documents (protocols, CRFs, study reports) and processes.
Expert knowledge of FDA and ICH regulations, and industry standards applicable to data management.
Advanced understanding of the drug development process and cross-functional interfaces with data management.
Experience in budget planning and management, with a focus on ensuring adherence to functional budgets.
Benefits of Working at ICON:
Competitive salary and a range of benefits designed to focus on well-being and work-life balance.
Annual leave entitlements, health insurance offerings, and competitive retirement planning options.
Global Employee Assistance Programme for 24-hour support for you and your family.
Life assurance, flexible country-specific optional benefits, and other offerings like childcare vouchers and discounted gym memberships.
At ICON, inclusion & belonging are fundamental to our culture. We are committed to providing a workplace free of discrimination and harassment.
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