Note: The job is a remote job and is open to candidates in USA. Spark Life Solutions Inc is seeking a Senior Clinical Data Manager to lead data management activities for assigned clinical studies. The role oversees study documentation, database setup, data review and reconciliation, CRO and vendor activities, clinical trial reporting support, process development, and training for junior staff.
Responsibilities
- Serve as the data management lead on assigned studies, representing DM on cross-functional study teams and providing input on timelines and deliverables
- Author and review study-level data management documents, including Data Management Plans, CRF annotations, data transfer specifications, coding conventions, and reconciliation plans
- Oversee database setup, migrations, and updates, including coordination and execution of UAT
- Lead internal data review planning and coordinate cross-functional listing review activities
- Perform scheduled and ad hoc data listing review; generate and resolve queries in EDC
- Execute external data reconciliation and SAE reconciliation in accordance with SOPs
- Manage and monitor CRO and vendor data management activities, maintaining effective working relationships with counterparts
- Distribute and review data management metrics, listings, and reports
- Support statisticians and statistical programmers in the production of clinical trial reports and other study deliverables
- Contribute to departmental SOP, template, and process development
- Provide training and guidance to junior data managers and clinical data associates
Skills
- Bachelor's degree in life sciences, health sciences, mathematics, computer science, or a related field
- Minimum of 8 years of data management experience in the pharmaceutical or biotechnology industry
- Working knowledge of ICH, FDA, and GCP regulations and guidelines
- Experience with EDC systems and industry thesauri (MedDRA, WHO Drug)
- Familiarity with CDISC, SDTM, and CDASH standards
- Oncology experience strongly preferred
- CRO or service provider management experience a plus
Benefits
- Remote work
Company Overview
Company H1B Sponsorship