Senior Study Manager

The SeniorStudyManager(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.

Overview

Key Responsibilities

Study Planning & Start-Up

• Lead operational planning, including develop and manage clinicalstudytimelines.
• Co-lead protocol development and operational feasibility assessments.
• Overseestudystart-up activities, including site selection, feasibility, and vendor onboarding.

StudyExecution

• Provide day-to-day operational leadership for assigned clinical trials, including review and approval of keystudydocuments.
• Manage CROs, vendors, and clinical sites to ensure quality and timelines.
• Trackstudymilestones, recruitment, and data quality. Assess performance metrics.
• Identify and mitigate operational risks and issues.
• Select and manage external vendors (CROs, central labs, imaging vendors, etc.).
• Support contracts revision and budget definition,

Data & Reporting

• Monitor data quality and cleaning activities.
• Support database lock and clinicalstudyreport (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 forstudyteams.

Coordinate with:

• Clinical Development
• Data Management
• Regulatory Affairs
• Clinical Supply

Present periodicstudystatus 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 asStudyManager.

Experience (continued): 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: SAD/MAD, proof-of-concept, and dose-escalation studies.

Skills: Strong project management and leadership skills.

Compliance: Deep understanding of ICH-GCP and regulatory requirements.

Communication: Strong communication abilities.

Multitasking: 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-functionalstudyteams.

Interact with CRO partners and clinical sites.