Senior Clinical Study Manager: Early-Phase Immunology

Otsuka Pharmaceutical Co., Ltd.; United States; On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match and retirement benefits

Paid holidays and PTO

Job summary

Otsuka is seeking a Senior Clinical Study Manager to oversee early phase clinical studies (P1-2a) in the United States, coordinating with cross functional teams, ESPs, CROs and internal departments to ensure compliant, on-time trial execution within budget.

You will contribute to study documents, protocol review, budgeting, resourcing, risk mitigation and TMF readiness while guiding the clinical team to maintain data integrity and regulatory compliance across portfolios.

Qualifications

• Oversee complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications.
• Thorough knowledge of CROs, outsourcing, and SOW evaluation.
• Strong understanding of regulatory requirements and clinical program science.
• Experience with Microsoft Office and clinical trial software tools.

Responsibilities

• Provide oversight and management of clinical studies in accordance with regulations and GCP.
• Contribute to development/review of critical study documents (protocols, ICFs).
• Identify and select CROs and ESPs; manage vendor relationships.

Skills

First-in-Human trials knowledge

Vendor & CRO oversight

GCP/ICH regulatory knowledge

Cross-functional leadership

Communication & planning

Microsoft Office suite

Clinical trial software (eCRFs/CTMS/IR

Education

Bachelor's Degree or RN

Tools

MS Office

Clinical trial software (eCRFs/IRT/CTMS)

Job description

Otsuka is seeking a Senior Clinical Study Manager to oversee early phase clinical studies (P1-2a) in the United States, coordinating with cross functional teams, ESPs, CROs and internal departments to ensure compliant, on-time trial execution within budget.

You will contribute to study documents, protocol review, budgeting, resourcing, risk mitigation and TMF readiness while guiding the clinical team to maintain data integrity and regulatory compliance across portfolios.