Embedded Clinical Project Manager - Pharma Innovation

Socket.dev; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

Socket.dev is seeking a Project Manager to work with a pharmaceutical client on operational transformation, process optimization, and vendor management throughout clinical development activities.

You will coordinate data standards, support knowledge transfer workshops, and ensure documentation and inspection readiness while leading cross-functional teams and communicating project status to sponsors and internal stakeholders.

Qualifications

• Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field.
• 5+ years of experience in clinical research, CRO, pharmaceutical, or biotechnology environments.
• 2+ years of project management or study management experience.
• Working knowledge of the clinical development lifecycle.
• Deep understanding of Clinical/Statistical Programming (Data ingestion, SDTM, ADaM, TFLs, Ad Hocs, ISS/ISE, etc.)
• Understanding of the relationship between source/clinical data, SDTM datasets, ADaM datasets, tables, listings, and figures.
• Experience coordinating cross-functional teams, including Data Management, Biostatistics, Statistical Programming, and Clinical Operations.
• Strong organizational, communication, stakeholder management, and problem-solving skills.

Responsibilities

• Coordinate and track clinical data standards and statistical programming activities across clinical programs
• Support operational transition activities including organizing workshop for knowledge transfer, identifying/maintaining procedural documents, training planning and creating checklist and documentation inventory.
• Support inspection readiness and ensure appropriate project documentation is maintained.
• Develop and maintain task lists, process flow, project plans, timelines, resource forecasts, risk logs, and communication plans.
• Help to build internal portal to support future activities.
• Support to update SOPs as needed.
• Facilitate cross-functional project meetings and communicate project status to internal teams and sponsor stakeholders.
• Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.

Skills

Cross-functional coordination

Project management

Communication skills

Clinical data concepts

Problem-solving

Education

Bachelor's degree in Life Sciences, Statistics, Computer Science, or related field

Tools

SDTM

ADaM

TFLs

ISS/ISE

Job description

Socket.dev is seeking a Project Manager to work with a pharmaceutical client on operational transformation, process optimization, and vendor management throughout clinical development activities.

You will coordinate data standards, support knowledge transfer workshops, and ensure documentation and inspection readiness while leading cross-functional teams and communicating project status to sponsors and internal stakeholders.