Senior Clinical Research Associate I
ROLE OVERVIEW
Pfizer’s Senior Clinical Research Associate I role is a pivotal site-facing position within Pfizer’s global clinical development organization. Based in Mumbai, this CRA will manage and monitor investigator sites for complex trials, often in oncology, vaccines, internal medicine or infectious diseases. The role directly protects patient safety, data integrity and regulatory compliance while accelerating enrollment, database release and close-out. As Pfizer expands its India clinical portfolio, experienced monitors who can partner with investigators, resolve site issues and uphold ICH-GCP are critical to bringing new therapies to patients. This is a compelling opportunity to deepen therapeutic expertise, work in a matrix global team and build a pathway toward clinical operations leadership, site care partnership or trial management in India’s growing life-sciences sector.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage assigned investigator sites from feasibility and site activation through routine monitoring, database lock and close-out in line with the Study Monitoring Plan.
- •Conduct on-site and remote monitoring visits, including SIV, IMV, COV, and ensure ICH-GCP, local regulations and Pfizer SOP compliance.
- •Serve as primary site contact, build investigator relationships, support enrollment and resolve recruitment, protocol and operational issues.
- •Monitor AEs/SAEs, collaborate with Drug Safety Unit, follow up with sites to obtain complete and accurate safety reports within timelines.
- •Review and resolve data queries, protocol deviations, TMF documents, site follow-up letters and clinical supply accountability.
- •Develop CAPAs for site non-compliance, track corrective actions and support audit/inspection readiness and quality event remediation.
- •Mentor junior CRAs, act as SME for CRA processes and participate in process improvement or local working groups.
- •Ensure investigational product oversight, including receipt, storage, accounting and destruction at assigned sites.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor’s degree in life sciences, nursing, pharmacy, medical background or equivalent professional qualification.
- Minimum 3 years’ clinical research site monitoring experience; at least 2 years in oncology strongly preferred.
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
- Global clinical trial experience and fluency in English plus local Indian language(s).
- Valid driver’s license and passport; willingness to travel 60–80% within region, with occasional international/weekend travel.
- Proven ability to work in matrix teams, influence stakeholders and manage complex site issues.
- Demonstrated ability to support sponsor regulatory interactions, inspections and protocol feasibility assessments.
PREFERRED QUALIFICATIONS
- •Oncology monitoring experience
- •Vaccines/Internal Medicine/Infectious Diseases
- •Global clinical trial exposure
- •CAPA and quality event remediation
- •CTMS/eTMF systems proficiency
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation. It is dedicated to the discovery, development, manufacturing, marketing, and sale of medicines and vaccines worldwide. The company focuses on breakthrough science to deliver innovative treatments across various therapeutic areas to improve health outcomes.
EXPECTED CAREER ROADMAP
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