Senior Clinical Study Manager — Early-Phase Immunology

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid time off

Job summary

Otsuka is seeking a Sr. Manager, Clinical Management for early-phase immunology/autoimmune studies in the United States.

Responsibilities include overseeing planning, execution, and completion of P1–P2a trials in accordance with GCP and SOPs, with CROs and ESPs coordination and budget oversight. The role requires strong leadership, regulatory knowledge, and cross-functional collaboration, plus the ability to travel up to 25% as needed.

Qualifications

• Experience leading early-phase clinical trials (P1–P2a) in immunology/autoimmune indications.
• Strong knowledge of ICH GCP and regulatory requirements.
• Ability to manage CROs, ESPs, and investigative sites.
• Excellent communication, organization, and leadership skills.

Responsibilities

• Oversee planning, execution, and completion of early-phase trials per regulations and timelines.
• Develop and review critical study documents (protocols, informed consent forms).
• Provide guidance to clinical team and manage cross-functional communications.
• Forecast expenditures and manage study budget to meet forecasts.
• Ensure TMF completeness and inspection readiness.

Skills

Clinical trial management

Immunology/autoimmune

Budgeting

Vendor management

Leadership

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s Degree or RN

Tools

eCRFs/IRT/CTMS

MS Office

Job description

Otsuka is seeking a Sr. Manager, Clinical Management for early-phase immunology/autoimmune studies in the United States.

Responsibilities include overseeing planning, execution, and completion of P1–P2a trials in accordance with GCP and SOPs, with CROs and ESPs coordination and budget oversight. The role requires strong leadership, regulatory knowledge, and cross-functional collaboration, plus the ability to travel up to 25% as needed.