Headquartered in Mumbai, Pfizer Products India Pvt Ltd (PPIPL) is a wholly owned subsidiary of Pfizer Inc. The company is engaged in importing, trading, marketing and distribution of pharmaceuticals products across key therapy areas such as Oncology, Rare Diseases and Anti-infectives.

Responsibilities in Job

The Study Operations Manager (cSOM) plays a pivotal role in managing regional and country-level activities from study startup through execution and closeout. Key responsibilities include:

Study Management

• Oversee regional/country-level implementation of Startup and Site Activation Plans.
• Develop and execute country-level recruitment strategies.
• Manage regional/country-level study startup, conduct, and closeout activities.
• Ensure compliance with ICH/GCP standards, SOPs, and local regulatory requirements.

Stakeholder Coordination

• Partner with Global Study Manager, Site Intelligence Lead, Site Care Partners, and other stakeholders.
• Lead Local Study Teams and provide protocol-level guidance.
• Ensure timely bidirectional communication between global and local teams.

Vendor and Site Oversight

• Manage country-level vendor deliverables.
• Oversee Site Care Partners and ensure resolution of site-level issues.
• Drive effective site recruitment planning and implementation.

Risk Management and Quality

• Identify and mitigate risks during study startup and execution.
• Ensure audit/inspection readiness.
• Manage quality events and ensure timely resolution.

Additional Responsibilities

• Drive data cleaning deliverables and support implementation of Pfizer’s Site Technology Experience systems.
• Oversee submission strategies to Health Authorities and Ethics Committees.
• Support implementation of new tools and technologies such as eConsent and remote source access.

Qualifications

• Education: MBA/MS with 3+ years of relevant experience, or BA/BS with 5+ years of relevant experience. A scientific or technical degree is preferred.
• Experience:
  • Demonstrated clinical research experience.
  • Experience in managing country-level operational activities and vendors.
  • Familiarity with study and quality management.
• Knowledge:
  • Working knowledge of Good Clinical Practice (GCP).
  • Understanding of clinical and regulatory operations.

Skills

• Expertise in using study/site dashboard and reporting tools.
• Detail-oriented with strong technical expertise.
• Proficiency in strategic planning, risk identification, and critical path analysis.
• Excellent verbal and written communication skills.
• Adaptability to new technologies and processes.
• Effective problem-solving and analytical skills.
• Ability to work in a matrix management environment.

Application Link

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