Senior Clinical Study Manager: Early Phase Immunology (Remote)

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

Benefits offered by this job

Medical insurance

Dental insurance

401(k) match

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Clinical Study Manager to oversee EARLY PHASE ($P1-2a$) clinical studies remotely in the United States.

You will coordinate with internal departments, ESPs, CROs, and investigative sites to plan, execute, and complete trials in compliance with GCP, ICH, and Otsuka SOPs, within scope and budget. You will mentor the clinical team, prepare critical study documents, monitor expenditures, and drive risk mitigation and data integrity.

Qualifications

• Bachelor’s Degree or RN; 10+ years in industry with 7+ years in clinical trial management
• Experience overseeing complex First-in-Human SAD/MAD/POC trials in immunology/autoimmune indications

Responsibilities

• Oversee planning, execution and completion of clinical trials per GCP/ICH and Otsuka SOPs
• Contribute to development/review of critical clinical documents (protocols, informed consent forms)
• Identify/evaluate CROs and ESPs; select investigators and vendors
• Provide leadership to clinical teams to ensure timely, compliant trial conduct
• Communicate progress across cross-functional departments and manage scope/resource changes
• Forecast expenditures and monitor study budgets; report variances to leadership
• Ensure TMF completeness, timeliness and quality; assist in inspection readiness
• Represent Clinical Management in protocol reviews and cross-portfolio initiatives
• Support risk mitigation strategies with ESPs and vendors
• Supply supervisory responsibilities including training and performance feedback

Skills

Communication

Organization

Planning

Analytical

Problem solving

People management

Travel up to 25%

Education

Bachelor’s Degree or RN

Tools

CTMS

eCRFs

IRT

MS Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Clinical Study Manager to oversee EARLY PHASE ($P1-2a$) clinical studies remotely in the United States.

You will coordinate with internal departments, ESPs, CROs, and investigative sites to plan, execute, and complete trials in compliance with GCP, ICH, and Otsuka SOPs, within scope and budget. You will mentor the clinical team, prepare critical study documents, monitor expenditures, and drive risk mitigation and data integrity.