Job Description
Position: Clinical Site Manager
Employment Type:
Permanent
Start Date:
Flexible
Location:
Remote (Japan / APAC-aligned)
Company Overview
The client is a
top-tier global pharmaceutical organisation
with a strong research and development focus and a significant presence across APAC and other major regions. The organisation is committed to developing innovative therapies for unmet medical needs, operating under high standards of ethics, quality, and regulatory compliance.
Role Summary
The Clinical Site Manager acts as the
primary point of contact between the sponsor and investigational sites
, with responsibility for ensuring inspection readiness and high-quality trial delivery from study start-up through site close-out.
The role focuses on
site oversight, compliance, and relationship management
, working closely with cross-functional study teams in a matrix environment. The position may also provide mentoring support to less experienced site managers or oversight of contract staff.
Key Responsibilities
- Serve as the main sponsor contact for assigned sites, ensuring compliance with protocol, SOPs, GCP, and applicable regulations
- Manage site start-up, initiation, monitoring (including remote monitoring), ongoing site management, and close-out activities
- Drive inspection readiness and implementation of risk-based monitoring at the site level
- Ensure site facilities, staffing, training, and documentation remain adequate throughout all trial phases
- Ensure documentation complies with ALCOA-CCEA principles
- Support site feasibility and pre-study assessments where required
- Partner with study teams to accelerate site activation timelines
- Support site-level recruitment strategies in collaboration with other functions
- Oversee investigational product and non-IMP supplies, including storage, accountability, return, and destruction
- Ensure timely data entry, query resolution, and overall data quality
- Ensure all AEs and SAEs are reported within required timelines
- Maintain complete, accurate, and timely trial documentation and monitoring reports
- Support CAPA activities related to audits and quality findings
- Prepare sites for close-out and conduct final close-out visits
- Build strong working relationships with investigators, coordinators, and site staff
- Participate in Health Authority and IEC/IRB submissions and notifications as required
The role may manage
up to 10 sites across 2–4 protocols
, depending on complexity and activity.
Qualifications
Required
- Bachelor's degree with 5+ years' experience in pharmaceutical drug development or equivalent
- Minimum 5 years' experience in site monitoring and/or site management
- At least 2 years' experience in Oncology, Ophthalmology, Gene Therapy, or another directly relevant therapeutic area
- Strong knowledge of GCP, local regulations, and clinical trial processes
- Strong critical thinking and problem-solving skills
- Proficiency with clinical systems and IT tools
- Willingness to travel up to 40%, including overnight stays
- Strong written and spoken English
- Depending on region, fluency in the local language may be required
Preferred
- Experience working in matrix and cross-functional teams
- Experience in a Lead CSM or equivalent role
- Experience mentoring junior site managers or monitors
- Experience in early-phase development studies
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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