Project Manager – Clinical Research Pathology Services

Role Type and Location

• Work from home role - this role requires you to be based full time in the East Coast, USA.  

Eligibility to work 

• Unfortunately, we cannot offer USA based Visa sponsorship for this full time USA BASED role. 

Role Summary

We are seeking a proactive and detail-oriented Project Manager to support the delivery of pathology-focused clinical trial projects at Diagnexia Analytix. Sitting under the Clinical Trial Manager, this role will act as the operational driver of projects — ensuring that timelines, deliverables, and quality standards are met across complex, multi-stakeholder clinical studies.

The Project Manager will not design the science, but will make sure the science happens: coordinating vendors, labs, pathologists, and internal teams, while keeping communication clear and projects audit-ready.

Key Responsibilities

• Project Delivery & Coordination
  • 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.
  • Pathologist Management, training and communication
    
    
• Stakeholder Communication
  • 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.
    
    
• Quality & Compliance
  • 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.
    
    
• Risk & Change Management
  • Maintain a risk register for timelines, logistics, and deliverables.
  • Coordinate structured change control processes when scope or timelines shift.

Required Skills & Experience (Must-Have)

• 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.

Preferred Skills & Experience (Nice-to-Have)

• Exposure to pathology, histology, or biomarker assay workflows.
  Experience coordinating pathologists and pathology vendors.
  Familiarity with digital pathology platforms (WSI, image hosting, secure data transfer).
• Therapeutic area experience in oncology, immunology, or liver disease trials.
  Formal PM certification (PMP, PRINCE2) or Lean/Agile training.
• Strong interpersonal skills: able to “manage up” to senior stakeholders while motivating delivery teams.
• Experience in a scale-up/fast-growing environment.

Ideal Candidate Profile

A “doer” who thrives on making things happen in complex clinical projects. Comfortable working alongside scientific leaders while taking responsibility for operations, timelines, and compliance. Highly organized, proactive, and able to bring structure and accountability to dynamic, multi-stakeholder studies.

What are the benefits of working with Deciphex

💰 Competitive salary with annual performance-based increases. Rewarding your impact and growth

🩺 Healthcare benefit