The Senior Study Manager (SSM) is responsible for the end-to-end operational management primarily for early-phase clinical trials (Phase I – including FIH and II), but also able to manage late-phase studies (Phase IIb, III, and IV) and observational studies. The role ensures studies are delivered on time, within budget, and in compliance with regulatory requirements, GCP, and company SOPs.
Key Responsibilities
Study Planning & Start‐Up
Lead operational planning, including develop and manage clinical study timelines.
Co‐lead protocol development and operational feasibility assessments.
Oversee study start‐up activities, including site selection, feasibility, and vendor onboarding.
Study Execution
Provide day‐to‐day operational leadership for assigned clinical trials, including review and approval of key study documents.
Manage CROs, vendors, and clinical sites to ensure quality and timelines.
Track study milestones, recruitment, and data quality. Assess performance metrics.
Identify and mitigate operational risks and issues.
Vendor & CRO Management
Select and manage external vendors (CROs,

central labs, imaging vendors, etc.).
Support contracts revision and budget definition.
Ensure vendor deliverables meet study expectations.
Data & Reporting
Monitor data quality and cleaning activities.
Support database lock and clinical study report (CSR) preparation.
Quality & Compliance
Ensure studies comply with:
ICH‐GCP guidelines
Regulatory requirements
Company SOPs
Support inspection readiness and audits.
Cross‐Functional Collaboration
Act as the primary operational contact for study teams.
Coordinate with:
Clinical Development
Data Management
Biostatistics
Regulatory Affairs
Pharmacovigilance
Clinical Supply
Present periodic study status updates to internal governance meetings.
Must‐have
Education: master's degree in life sciences, pharmacy, or related field.
Experience: 6‐8 years in clinical research as Study Manager.
Strong experience managing early‐phase clinical trials

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