Remote Senior Clinical Study Manager — Early-Phase Immunology

Otsuka America Pharmaceutical Inc.; Phoenix (AZ); Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager, Clinical Management for early phase immunology/autoimmune studies. You will oversee planning, execution, and completion of trials in compliance with GCP/ICH and Otsuka SOPs, coordinating with CROs and ESPs to meet timelines and budget.

Responsibilities include leading cross-functional teams, developing study documents, and ensuring TMF readiness, while forecasting expenditures and ensuring quality across portfolios.

Qualifications

• Bachelor’s Degree or RN with 7+ years in clinical trial management.
• Experience leading immunology/autoimmune early phase trials.

Responsibilities

• Oversee planning, execution and completion of early phase trials in immunology/autoimmune indications.
• Coordinate with CROs, ESPs, and investigative sites to ensure compliance and timelines.
• Monitor budgets, forecast expenditures, and manage resources.
• Provide leadership to clinical teams and ensure study documentation (TMF) is complete.

Skills

Leadership

Project management

GCP/ICH knowledge

Cross-functional collaboration

Communication

Education

Bachelor’s Degree or RN

Tools

eCRF systems

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager, Clinical Management for early phase immunology/autoimmune studies. You will oversee planning, execution, and completion of trials in compliance with GCP/ICH and Otsuka SOPs, coordinating with CROs and ESPs to meet timelines and budget.

Responsibilities include leading cross-functional teams, developing study documents, and ensuring TMF readiness, while forecasting expenditures and ensuring quality across portfolios.