We are seeking an experienced Technical Project Manager (TPM) to lead cross-functional technology projects supporting R&D, bioinformatics, clinical data, and pharmacovigilance within a GxP-regulated life sciences environment. The ideal candidate will manage end-to-end project delivery, coordinating scientists, engineers, QA, validation, and vendors while ensuring projects are delivered on time, within scope, and audit-ready.
Key Responsibilities:
- Lead technical projects across bioinformatics, biometrics, clinical data management, and pharmacovigilance.
- Coordinate implementations involving Veeva Vault, Seqera/Nextflow, Dagster, Illumina BaseSpace, Posit (Connect/Workbench), SAS, and AWS.
- Manage project plans, timelines, budgets, risks, and stakeholder communications using Agile/Waterfall methodologies.
- Support GxP compliance, Computer System Validation (CSV/CSA), documentation, and audit readiness.
- Collaborate with cross-functional teams, IT, QA, validation, and external vendors to ensure successful project execution.
Required Skills:
- 8+ years of Technical Project Management experience in Life Sciences, Biotech, Pharma, or Clinical Research.
- Hands-on exposure to Veeva Vault, Nextflow/Seqera, Dagster, Illumina BaseSpace, Posit, SAS, Git, and YAML.
- Strong knowledge of GxP, CSV/CSA, ALCOA+, Agile, JIRA, Confluence, and MS Teams.
- Experience with AWS/cloud environments, clinical data systems, and bioinformatics workflows is highly preferred.
- PMP, CSM, or SAFe certification is a plus.