Pfizer India is seeking an experienced Site Care Partner (Site Clinical Operations) to join their Mumbai team. This pivotal role acts as the key liaison between investigative sites and Pfizer, ensuring smooth site activation, start-up, and patient recruitment across clinical studies. If you have a strong background in clinical operations, site management, and regulatory compliance, this full-time opportunity is your chance to advance your career in pharmaceutical clinical research.
Key Responsibilities
As a Site Care Partner, your responsibilities will include:
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- Site Start-Up & Activation: Qualify and activate sites, coordinate PTA, ICD finalization, SIV, and ensure readiness for first subject first visit (FSFV).
- Site Relationship Management: Build and maintain strong relationships with investigative sites, CROs, and internal stakeholders.
- Recruitment & Enrollment: Strategically support patient recruitment and enrollment consistent with local and global study plans.
- Quality & Compliance: Monitor site-level quality using tools like SQRD and IRMS, identifying risks and implementing mitigation plans.
- Study Support & Coordination: Provide guidance on site issues, manage investigational product and ancillary supplies, and coordinate with local RA, CTRO, and SAP teams.
- Clinical Study Lifecycle Support: Assist in site feasibility, protocol defense with Subject Expert Committees, and provide insights for site selection.
- Reporting & Analytics: Review site reports, escalate compliance concerns, and contribute local intelligence to optimize study performance.
Qualifications & Skills
Educational Requirements:
- Graduate or Post-Graduate in Pharmacy, Biotechnology, or Nursing.
- MBBS/MD preferred with 8–12 years of clinical research experience.
Experience & Competencies:
- Proven experience as a Site Monitor/CRA with site management expertise.
- Hands-on experience in site start-up, activation, conduct, and close-out.
- Strong understanding of GCP, ICH guidelines, and local regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Proficiency in English; local language skills are a plus.
- Willingness to travel nationally and internationally.
Benefits
- Hybrid work model with flexible work arrangements.
- Exposure to global clinical trials and strategic site management.
- Opportunity to collaborate with cross-functional teams across Medical Affairs, Regulatory, and Commercial divisions.
- Career growth in a global pharmaceutical company.
Application Instructions
