Senior Clinical Research Manager

Job Overview :

We are seeking an experienced and strategic Senior Manager of Clinical Research to lead and execute our clinical study programs. This role is pivotal in designing, managing, and delivering high-quality clinical evidence to achieve regulatory approvals (PMDA,CE,FDA), support product commercialization, and contribute to scientific publications. The ideal candidate is a proactive leader with a deep understanding of Good Clinical Practice (GCP), medical device regulations, has worked with CRO in clinical trials execution and has experience in managing clinical trials from concept to closure.

Key Responsibilities

Clinical Strategy & Study Design

• Contribute to the development of the global clinical evidence strategy for new and existing products.
• Lead the design and development of clinical study protocols, case report forms (CRFs), statistical analysis plans (SAP), and other key study documents.
• Conduct feasibility assessments for new clinical programs.

Study Execution & Management

Regulatory Compliance & Documentation

Data Management & Analysis

Leadership & Cross-Functional Collaboration

Qualifications & Experience