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Technical Project Manager

3B Staffing LLC

100% remote must work EST hours

Required Qualifications
• 8+ years of technical project management in life sciences, biotech, pharma, or clinical research technology, delivering complex, cross-functional systems projects.
• Demonstrated fluency in a niche scientific-computing stack - direct, hands-on exposure to several of: Veeva Vault, Seqera/Nextflow, Dagster, Illumina BaseSpace, Posit (Connect/Workbench/Package Manager), and SAS.
• Ability to read and reason about YAML and configuration-as-code, pipeline manifests, and version-controlled artifacts (Git).
• Working knowledge of GxP, computer system validation, and data integrity requirements in a regulated (FDA/EMA) environment.
• Strong command of agile delivery and tooling (JIRA, Confluence) plus collaboration platforms (MS Teams).
• Excellent written communication - able to produce clean, professional, audit-ready documentation and to tailor detail to the audience.
• Bachelor's degree in a life sciences, bioinformatics, data, computer science, or related discipline (or equivalent experience).

Title: Technical Project Manager


Location: Cambridge, MA

Position Summary


We are seeking a hands-on Technical Project Manager (TPM) to lead and support technology projects across our R&D dry-lab ecosystem - the platforms, pipelines, and integrations that turn genomic and clinical data into research and regulatory decisions. This person will manage cross-functional delivery across bioinformatics, biometrics, data management, and pharmacovigilance, coordinating scientists, engineers, validation, quality, and external vendors within a GxP-regulated environment.


This is a role for someone who is genuinely comfortable in a niche scientific-computing stack. You will be conversant in Veeva Vault modules, genomic data science platforms (Seqera/Nextflow, Dagster, Illumina BaseSpace), and biometrics tooling (Posit Connect, Workbench, Package Manager, SAS), and you will be able to read a YAML configuration or a pipeline manifest and understand what a change actually means. You do not need to be the engineer, but you must be able to speak the language, challenge assumptions, and keep highly technical teams aligned to scope, timeline, and compliance.

Required Qualifications
• 8+ years of technical project management in life sciences, biotech, pharma, or clinical research technology, delivering complex, cross-functional systems projects.
• Demonstrated fluency in a niche scientific-computing stack - direct, hands-on exposure to several of: Veeva Vault, Seqera/Nextflow, Dagster, Illumina BaseSpace, Posit (Connect/Workbench/Package Manager), and SAS.
• Ability to read and reason about YAML and configuration-as-code, pipeline manifests, and version-controlled artifacts (Git).
• Working knowledge of GxP, computer system validation, and data integrity requirements in a regulated (FDA/EMA) environment.
• Strong command of agile delivery and tooling (JIRA, Confluence) plus collaboration platforms (MS Teams).
• Excellent written communication - able to produce clean, professional, audit-ready documentation and to tailor detail to the audience.
• Bachelor's degree in a life sciences, bioinformatics, data, computer science, or related discipline (or equivalent experience).

Preferred Qualifications
• Background in molecular biology, genomics, or bench/wet-lab research that informs collaboration with scientific teams.
• Experience supporting bioinformatics/NGS data workflows and HPC or cloud (AWS) compute environments.
• Familiarity with pharmacovigilance/safety systems and clinical data management processes (EDC/CDMS, data transfers, reconciliation).
• Exposure to Python/R for data workflows, and to containerized/reproducible environments.
• PMP, CSM/SAFe, or comparable project-management certification.

Functional Areas Supported


The TPM operates as an IT business partner across multiple R&D functions. Project load will shift with portfolio priorities, so adaptability across these areas is essential:


Bioinformatics & Genomics


Sequencing data flows and pipeline orchestration (Nextflow/Seqera, Dagster), Illumina BaseSpace Sequence Hub, sample/run metadata, HPC and cloud compute environments.


Biometrics & Statistical Computing


Posit Connect, Workbench, and Package Manager environments; SAS programming environments; reproducible R/Python analysis and reporting for statistical and PK/PD teams.


Data Management


Clinical and research data integration, EDC/CDMS data flows, transfer specifications, reconciliation, and audit-ready data lineage.


Pharmacovigilance


Safety data system support and integrations (case intake, signal data feeds, safety reporting), coordination with drug safety on data quality and timelines.


Clinical & Regulatory Systems


Veeva Vault (Clinical, Safety, eCOA/CDMS) configuration coordination, connectors, and regulated document/data workflows.


Adhoc Business Functions


Cross-functional initiatives spanning Quality Assurance, Clinical Operations, and external vendors as portfolio needs arise.

Key Responsibilities


Project Leadership & Delivery
• Lead the full delivery lifecycle for R&D dry-lab technology projects - intake, requirements, design coordination, build, validation, deployment, and hypercare - using waterfall and agile methods and clearly staged milestones.
• Build and maintain project plans, backlogs, and boards (MS Teams), running scheduling, and stakeholder reviews with disciplined follow-through.
• Manage scope, timelines, dependencies, budgets, and risks across concurrent workstreams, escalating early with proposed mitigations rather than surprises.
• Own decision logs, RAID logs, and status reporting so that progress and blockers are transparent to leadership and functional partners.


Technical Coordination (Dry-Lab Stack)
• Coordinate work on genomic data science platforms - Seqera Platform / Nextflow pipeline deployments, Dagster orchestration, and Illumina BaseSpace data flows - translating scientific requirements into technical work items.
• Support biometrics environments (Posit Connect, Workbench, Package Manager, SAS), including publishing workflows, environment/package governance, and reproducibility needs for statistical teams.
• Coordinate Veeva Vault configuration, connector, and integration efforts across Clinical, Safety, and CDMS/eCOA modules.
• Review and reason about configuration-as-code artifacts - YAML manifests, pipeline configs, environment definitions - well enough to trace impact, question changes, and coordinate peer review and version control (Git).
• Partner with cloud/infrastructure teams (e.g., AWS S3, IAM, compute) to ensure environments are provisioned, secure, and fit for regulated use.


Compliance, Validation & Quality
• Drive projects to GxP and audit-ready standards, ensuring computer system validation (CSV/CSA), traceability, and data integrity (ALCOA+) are built in from the start, not retrofitted.
• Coordinate validation deliverables (URS, functional/design specs, test protocols, traceability matrices) with QA, validation, and system owners.
• Author and maintain high-quality documentation - process overviews and workflow diagrams - for both technical and business audiences.


Stakeholder & Vendor Management
• Serve as the connective tissue between scientific end users, IT, data management, biometrics, pharmacovigilance, bioinformatics, QA, and leadership.
• Manage external vendors and niche-technology partners - onboarding, statements of work, deliverable tracking, and holding vendors accountable to scope and quality.
• Support out-of-office coverage planning and knowledge continuity across the team, ensuring no single point of failure on critical systems.
Vacancy posted 5 days ago
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