Manager, Risk Based Data Monitoring and Validation job in Basking Ridge
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New Jersey (NJ),
Basking Ridge
| Job Code: | J3W7866QX5PB4ZCXTB0 |
| Employer: | Daiichi Sankyo, Inc. |
| Category: | Clinical Research |
| Job Type: | Full Time |
| Location | |
| Country: | United States |
| State: | New Jersey (NJ) |
| City: | Basking Ridge |
| Post Date: | 04/24/2024 |
| Description | |
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Job Description Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position supports Daiichi Sankyo's Risk Based Data Monitoring and Validation strategy. This role will assist in driving the connection between the identification of Critical to Quality data and processes, the Risk Assessment, and Data Validation with the goal of creating a culture shift to data-driven data quality. This position requires working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications, industry standards, and technical skills in working with data received from CROs and other external vendors. This position requires strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. Position is accountable for collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global submissions. Responsibilities - Leadership, Direction, and Strategy: Establishes Risk Based Data Monitoring and Validation (RBDMV) deliverables and expectations at the study level. Proactively identifies and manages risks to data quality and/or timelines at the study level and escalates issues to the DM Program/Asset lead. Acts as an extended member of the Study Team and collaborates with other line functions to achieve study deliverables focusing on data completeness, accuracy and quality. Is an ambassador and Subject Matter Expert (SME) for RBDMV. Participates in audits and inspections as appropriate/needed. - Project Management: Is accountable for the conduct of data monitoring and validation activities for assigned studies during study startup, study conduct or study closeout, and monitoring adherence to quality expectations and timelines. Complies with the protocol, Policies, SOPs, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. Serve as a lead to provide reporting and validation expertise to the assigned Daiichi Sankyo portfolio of studies. Function as technical resource to the study teams for data visualization and reporting tools. - Operational Efficiency / Continuous Improvement: May participate in process improvement initiatives. Support the adoption of technology improvements and tools clinical data management processes. Ability to drive projects to completion. Stays current with regulatory guidelines impacting essential functions and data requirements. Completes other projects and duties as assigned. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree in life sciences or related field (or equivalent experience) required Experience Qualifications - 4+ years clinical data management and/or related industry work experience in a medical device, pharmaceutical, or biotechnology company, or similar environment (e.g., CRO) required. - oncology, immunology, or complex disease clinical trial experience preferred Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. | |
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