Lead Clinical Scientist, Transplant
Biogen
Google Cloud Platform
Project Manager – Clinical Research Pathology Services
Deciphex
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Translate Statements of Work (SoWs) into actionable project plans, timelines, and trackers.
- Manage day-to-day execution, logistics, and operational workflows.
- Oversee sample flow, staining, scanning, and digital pathology processes.
- Serve as a central point of contact between sponsor, CRO, central labs, and internal teams.
- Organize and document sponsor calls, training sessions, consensus/adjudication meetings.
- Maintain action logs, decision records, and issue escalation pathways.
- Ensure all activities follow GCP/GCLP, ICH E6, and regulatory standards.
- Support preparation of validation reports, pathology manuals, final study reports, and archival outputs.
- Track QC metrics, deviations, CAPA actions, and maintain audit readiness.
- Maintain a risk register for timelines, logistics, and deliverables.
- Coordinate structured change control processes when scope or timelines shift.
Requirements
- Degree in life sciences, biomedical sciences, or a related discipline.
- 3–5 years’ experience in clinical trial project management, CRO operations, or translational/biomarker projects.
- Strong knowledge of GCP/GCLP and ICH E6 standards.
- Proven ability to deliver multi-stakeholder projects on time and within scope.
- Excellent organizational skills; able to manage multiple vendors, labs, and deliverables.
- Strong communication skills, with experience preparing reports, dashboards, and running status calls.
- Ability to anticipate issues, escalate appropriately, and drive solutions.
- Proficiency with project management tools (e.g., Smartsheet, MS Project, Asana) and shared document platforms.
Benefits
- Competitive salary with annual performance-based increases.
- Healthcare benefits, giving you peace of mind to focus on what you do best.
- Annual leave with service increments - Means more time to recharge and enjoy life outside work.
- Pension contributions, helping you build a secure future.
- Work with a world-class, high-performing team in a hyper-growth startup. You’ll earn fast, make an impact, and shape the future.
- Regular feedback and clear career growth opportunities. You keep developing and moving forward.
- A collaborative, supportive, multicultural team. Here you’ll feel valued and inspired every day.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial project managementCRO operationstranslational projectsbiomarker projectsGCPGCLPICH E6QC metricsCAPA actionsrisk management
Soft skills
organizational skillscommunication skillsproblem-solvingstakeholder managementissue escalationmulti-taskingproject deliveryanticipation of issueslogistics managementteam coordination
