Job Title:  SENIOR STUDY MANAGER

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 (Phase I – including FIH and II), but also able to manage late-phase studies (Phase IIb, III, and IV).

Knowledge of SAD/MAD, proof-of-concept, and dose-escalation studies.

Strong project management and leadership skills.

Strong vendor/stakeholder management experience.

Deep understanding of ICH-GCP and regulatory requirements.

Strong communication abilities.

Ability to manage multiple complex studies simultaneously.

Nice-to-have

Experience with observational studies.

Experience in rare diseases, neuroscience.

Familiarity with adaptive trial designs and clinical pharmacology studies.

PMP certification or project management training.

Typical Scope of the Role

Manage 1–3 clinical studies simultaneously.

Lead cross-functional study teams.

Interact with CRO partners and clinical sites.