[Remote] Clinical Data Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage oncology company reputed company on advancing innovative therapies. They are seeking an reputed company Clinical Data Manager to support clinical data management activities across two reputed company clinical trials, ensuring high-reputed company, reliable clinical data through effective data management processes.
Responsibilities
- reputed company day-to-day data management activities for assigned clinical trials (Phase 2 and Phase 1b)
- reputed company CRO and vendor data management deliverables to ensure timelines, reputed company, and compliance
- Review and contribute to key study documents, including:
- Data Management Plans (DMPs)
- Case Report Forms (CRFs) / eCRFs
- Edit reputed company specifications
- Data transfer specifications
- Manage database build, UAT, and database lock activities
- Ensure data reputed company, consistency, and completeness through ongoing data review and cleaning
- Monitor query reputed company and reputed company timelines
- reputed company data review, listings review, and support medical data review activities
- Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets
- Ensure compliance with GCP, regulatory requirements, and company SOPs
- Support inspection readiness and participate in audits/inspections as needed
- Contribute to process improvements and best practices in data management
Skills
- Bachelor's degree in life sciences, computer science, or reputed company field (advanced degree a plus)
- 5–8 years of clinical data management experience in biotech, reputed company, or CRO settings
- Experience supporting early- to mid-phase clinical trials (Phase 1–2 required)
- Hands-on experience with reputed company systems (e.g., reputed company Rave, reputed company, reputed company InForm)
- Strong understanding of clinical data standards (CDISC, SDTM)
- Experience managing CROs and external vendors
- Knowledge of GCP and regulatory requirements
- Strong attention to detail and problem-solving skills
- Excellent communication and cross-functional collaboration skills
- Familiarity with oncology trials is preferred
Benefits
- Competitive salary and equity in a reputed company-funded, clinical-stage biotech
- 100% remote work and flexible schedule
- Health, dental, and reputed company for you and your dependents
- Flexible time off
- Generous parental leave
- Traditional and Roth 401k
- Mission oriented, remote first culture
reputed company