Site Care Partner (Site Clinical Operations) – Pfizer
📍 Location: India – Mumbai
💼 Employment Type: Full-time
📅 Posted: 6 Days Ago
🆔 Job ID: 4943514
🏠 Work Model: Hybrid
About Pfizer
At Pfizer, we are in the relentless pursuit of breakthroughs that change patients’ lives. Every day, we innovate to make the world a healthier place.
Our purpose is guided by our core values — Courage, Excellence, Equity, and Joy — which define both what we achieve for patients and how we achieve it.
Pfizer Research & Development is the driving force behind our groundbreaking product pipeline, advancing life-changing medicines for patients across the globe.
Pfizer also offers competitive compensation and comprehensive benefits designed to meet the diverse needs of our colleagues.
Position Overview
The Site Care Partner (SCP) serves as a key point of contact for investigative sites throughout a study’s lifecycle — from site start-up and activation to study conduct and close-out.
This role ensures site readiness, supports recruitment, safeguards quality and patient safety, and strengthens investigator relationships while maintaining Pfizer’s high operational standards.
The SCP collaborates with cross-functional teams including CRAs, Site Activation Partners, Clinicians, Regulatory, and Medical Affairs to ensure seamless site operations and study delivery.
Key Responsibilities
1. Site Start-Up and Activation
Deploy GSSO (Global Site & Study Operations) site strategies to qualify and activate sites.
Support country and site selection through local intelligence, site feasibility input, and protocol feedback.
Conduct site start-up activities, including:
Pre-trial assessment (PTA)
Site activation checklist management
Informed Consent Document (ICD) finalization
Site Initiation Visit (SIV) coordination
Ensure all site documentation and system updates are completed for activation (PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF, etc.).
Collaborate with CRA/Site Monitor to ensure monitoring readiness before first patient visit (FSFV).
2. Relationship Management & Site Quality
Build and maintain strong relationships with investigator sites and strategic partners.
Provide scientific and operational support to local Medical Affairs, Regulatory, and Commercial teams.
Resolve escalated site issues related to study delivery (e.g., contracts, payments, or vendor coordination).
Monitor site-level recruitment and co-own enrollment delivery with CRA during study conduct.
Ensure effective management of Investigational Product (IP) and ancillary supplies across the study lifecycle.
3. Study Conduct and Close-Out
Review site monitoring reports and related issues for quality and consistency.
Support CRAs in developing strong investigator relationships and addressing compliance or training needs.
Proactively provide local intelligence and site performance insights to the Study Operations Manager.
Assist with import/export documentation for investigational materials and ensure regulatory compliance.
Qualifications and Skills
Education
Graduate or Postgraduate in Pharmacy, Biotechnology, or Nursing.
MBBS/MD or related field preferred.
Experience: 8–12 years total, with demonstrated experience in clinical site management.
Experience
Prior experience as a Site Monitor/CRA and in site start-up through close-out.
Proven understanding of Quality and Regulatory requirements.
Familiarity with Good Clinical Practice (GCP), ICH Guidelines, and local country regulations.
Technical & Behavioral Competencies
Strong computer literacy; ability to adapt to new technologies.
Excellent communication, presentation, and relationship management skills.
Effective in cross-functional collaboration and stakeholder management.
Ability to travel nationally and internationally as required.
Demonstrates initiative, problem-solving ability, and adaptability to process changes.
Fluent in English; proficiency in local language preferred.
Organizational Relationships
Reports to: DCSO (Director, Country Site Operations)
Collaborates with:
Global/Study Operations Manager
Start-Up Project Manager
Site Activation Partner (SAP)
Clinical Trial Assistant (CTA)
Site Monitor/CRA
Investigator Contracts Lead (ICL)
Feasibility and Analytics Leads
Signal Interpretation Lead
Regulatory and Medical Affairs Teams
Behavioral Attributes
Builds effective investigator and stakeholder relationships.
Demonstrates resilience in overcoming operational barriers.
Maintains high standards of quality, integrity, and compliance.
Effectively manages issues raised by sites to align Pfizer’s needs with site requirements.
Equal Opportunity Statement
Pfizer is an Equal Opportunity Employer and complies with all applicable EEO legislation in every jurisdiction where it operates.
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