Note: The job is a remote job and is open to candidates in USA. Belenos Biosciences is seeking an Associate Director / Director, Clinical Data Management to lead end-to-end data management strategy and execution across clinical programs. The role will oversee clinical data processes, CROs, vendors, systems, data integrity, regulatory compliance, and cross-functional support in a growing startup environment.
Responsibilities
- Lead end-to-end data management for multiple clinical studies, including study start‑up, database build, ongoing data review, and database lock
- Develop eCRF and ensure CDISC standards (CDASH, SDTM), edit checks, Data Management Plans, and data validation specifications
- Oversee EDC systems and integrations with IRT, eCOA, safety, PK/PD, and biomarker platforms
- Manage CROs and external vendors to ensure high-quality deliverables and adherence to timelines
- Ensure compliance with ICH‑GCP and support inspection readiness
- Partner cross functionally to support interim analyses, safety reviews, regulatory submissions, and clinical study reports
- Build scalable DM processes, SOPs, templates, and standards appropriate for a growing startup
- Provide protocol input to ensure data collection aligns with study endpoints.
Skills
- Bachelor's degree in life sciences, data science, statistics, or related fields
- 8–12+ years of clinical data management experience in biotech/pharma
- Experience supporting inspection readiness and regulatory submissions
- Strong expertise in EDC systems, eCRF design, edit checks, and database validation
- Deep knowledge of ICH‑GCP, CDISC, and regulatory expectations
- Proven ability to lead multiple studies and manage CROs in a start‑up environment
- Experience in biologics, immunology, or bispecific antibodies preferred
- Familiarity with PK/PD, immunogenicity, and biomarker data flows preferred
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