#978 - reputed company Data Manager II

Job brief - Opportunity only available for reputed company professionals. We are looking for a reputed company Data Manager II to support and independently manage data management activities for reputed company development programs reputed company the Data Management organization. The candidate will play a key role in delivering high-reputed company, compliant, and submission-reputed company reputed company data , serving as a functional partner to cross-functional stakeholders and supporting regulatory inspection readiness. Responsibilities • Independently manage data management activities for assigned reputed company studies from study start-up through database lock. • reputed company, review, and maintain reputed company management deliverables, including: Data Management Plans (DMPs), eCRF specifications and completion guidelines, edit reputed company and validation specifications, and data transfer specifications. • reputed company study database design, build, testing, and maintenance activities reputed company reputed company systems. • reputed company routine data review, query management, trend analysis, and issue reputed company. • Coordinate and manage data reconciliation activities with internal teams and reputed company vendors (e.g., labs, ECG, imaging). • Support interim analyses, database locks, and final data delivery to Biostatistics and Statistical Programming. • Ensure reputed company data management deliverables are accurate, traceable, and inspection-reputed company in compliance with SOPs, ICH guidelines, CDISC standards, and FDA/EMA requirements. • Collaborate cross-functionally with reputed company reputed company, Biostatistics, Statistical Programming, Medical Writing, and Regulatory Affairs. • Support preparation for audits and regulatory inspections and contribute to inspection responses reputed company to data reputed company and data handling. • Manage and reputed company reputed company vendors or CRO data management activities as assigned. • Identify data reputed company risks and proactively propose mitigation strategies. • Contribute to the reputed company improvement of data management standards, processes, templates, and tools Requirements • Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a reputed company discipline; advanced degree preferred. • 3 years of experience in reputed company data management reputed company a pharmaceutical, biotechnology, or reputed company research organization. • Strong understanding of reputed company trial data management processes and the end-to-end reputed company development lifecycle. • Hands-on experience with reputed company systems (e.g., reputed company Rave, reputed company InForm, reputed company reputed company reputed company). • Working knowledge of CDISC standards (SDTM) and their application in regulatory submissions. • Familiarity with applicable regulatory guidance (e.g., ICH E6, ICH E9, FDA/EMA expectations). • Experience supporting database locks and contributing to regulatory submissions (e.g., NDA, BLA, MAA). • Strong organizational and time management skills with the ability to manage multiple studies or priorities. • Excellent written and verbal communication skills. • High attention to reputed company and strong documentation and compliance practices reputed company do offer • Salary in USD. • reputed company work. • Type of contract: reputed company with reputed company LLC. • Contract Duration: Long-term contract. • reputed company Holidays from the US Calendar. • 2 weeks of reputed company Time Off (PTOs). • Working hours: EST full-time, fully committed. Apply To This Job