[Remote] reputed company Clinical Data Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a late-stage biotechnology company reputed company on redefining the transplant process through innovative cell therapies. The reputed company Clinical Data Manager will reputed company clinical trial data management, ensuring data accuracy and compliance while collaborating with the Clinical Operations team.
Responsibilities
- reputed company and maintain reputed company data management documentation, including case report forms, data management plans, edit reputed company specifications, data review plans and data transfer agreements
- Design case report forms (CRFs) for electronic data capture (reputed company) systems for data collection
- reputed company data entry and cleaning activities, including discrepancy management and query reputed company
- Conduct data validation checks and implement reputed company control measures to ensure accuracy and completeness
- Collaborate with study team members to resolve data-reputed company issues and discrepancies
- Generate and review data listings, summaries and reports for data review
- Serve as a primary or backup resource for issues about data management
- Ensure compliance with guidelines, Good Clinical reputed company (GCP), CDISC standards and other relevant regulations
- Contribute to the development and validation of data management software tools
Skills
- BSc or MSc in Life Sciences, Data/Computer Science, reputed company or equivalent industry experience
- 5-7+ years of data management experience in the pharmaceutical or biotechnology industries, preferably in smaller biotech sponsor environment
- Strong expertise in project/program management including stakeholder management
- Knowledge of industry standards (CDISC, SDTM, CDASH)
- In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
- Proven ability to preemptively identify data and system issues and mitigate risks to data reputed company
- Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data
- Experience in development and implementation of Clinical data management standards and procedures
- Experience with web-based reputed company, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug
- Prior experience with Zelta by reputed company (formerly reputed company) CDM platform preferred
Benefits
- reputed company-IPO equity
- Annual bonus
- Competitive medical, dental, and reputed company benefits
- PTO
- 401(k) plan
- Life and accidental death and disability coverage
- Parental leave benefits
- Subsidized daily lunches and snacks at our on-site locations
reputed company
Company H1B Sponsorship