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Senior Clinical Research Associate II

MUMBAI (IN)ONSITEPOSTED: 9/26/2026
PHARMAFull time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
Pfizer

ROLE OVERVIEW

Pfizer's Research & Development division in Mumbai is recruiting a Senior Clinical Research Associate II to own the operational delivery of clinical trials across India. This is a high-visibility, site-facing role at the intersection of science, regulation and execution: the CRA II protects patient safety, data integrity and protocol compliance while keeping complex studies on time and on budget. Because Pfizer's Indian sites increasingly contribute to global Phase I–III programmes, this position directly shapes how quickly new therapies move from protocol to regulatory submission. For a life-sciences professional with GCP depth and sponsor-side monitoring experience, the role offers structured mentoring responsibilities, budget and drug-supply ownership, and exposure to inspection readiness at a global scale — a genuine springboard into Clinical Trial Lead and Clinical Program Manager careers.

ROLE DEFINITION & RESPONSIBILITIES

  • •Lead and co-lead moderately complex global clinical studies, managing timelines, resources and site-level deliverables end to end.
  • •Develop realistic study startup and monitoring plans, then oversee execution against protocol, ICH-GCP and Pfizer SOPs.
  • •Perform on-site and remote monitoring visits, source data verification, informed consent review and follow-up letter documentation.
  • •Support country-level startup by reviewing essential documents and responding to regulatory authority and ethics committee questions.
  • •Forecast and manage the Clinical Trial Budget, tracking spend, site payments and investigator grants.
  • •Own drug supply management, ensuring accurate forecasting, shipping, accountability and return or destruction at sites.
  • •Act as primary point of contact for study decisions related to protocol, data collection and volunteer-related activities.
  • •Mentor junior CRAs by reviewing their work and support inspection readiness and corrective action planning.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • BA/BS in life sciences, pharmacy or nursing with at least 4 years of clinical research experience; or MBA/MS with 2+ years; or PhD/JD with any level of experience.
  • Proven sponsor or CRO experience within the pharmaceutical research and development sector, ideally across Phase I–III trials.
  • Demonstrated background in managing, conducting or participating in regulatory inspection processes.
  • Strong working knowledge of ICH-GCP, DCGI/CDSCO regulations, ethics committee requirements and Indian clinical trial legislation.
  • Solid project management capability, with the ability to handle multiple protocols and competing deadlines.
  • Excellent interpersonal skills and the ability to work effectively within cross-functional teams.
  • Fluent written and verbal English communication, with willingness to travel domestically to investigative sites.

PREFERRED QUALIFICATIONS

  • •Early-phase (Phase I) drug development experience
  • •Master's degree in clinical research or life sciences
  • •Proficiency with AI tools such as ChatGPT or Microsoft Copilot for workflow productivity
  • •Strong analytical, problem-solving and presentation skills
  • •Therapeutic experience in oncology, vaccines or internal medicine

REQUIRED VERIFIED SKILLS

ICH-GCP Compliance
On-Site and Remote Site Monitoring
Clinical Trial Budget Forecasting
Informed Consent and Source Data Verification
Regulatory Inspection Readiness
CDSCO and Ethics Committee Submissions
Investigational Drug Supply Management
Study Start-Up and Site Feasibility
Electronic Data Capture (Medidata Rave / Veeva)
Protocol Deviation Management

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

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.

TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare

EXPECTED CAREER ROADMAP

From Senior CRA II, the natural progression at Pfizer is to Clinical Trial Lead or Study Manager within 18–24 months, then Clinical Program Manager or Global Study Lead owning multi-country budgets and vendor oversight. Strong performers often pivot into Feasibility and Site Intelligence, Clinical Quality Assurance, Inspection Management or Regulatory Affairs. Because Pfizer's Indian hubs support global programmes, internal mobility to Singapore, Dublin or the United States is realistic for high performers. Externally, this experience maps cleanly onto CRA and CTM roles at IQVIA, Parexel, Syneos or ICON, or into sponsor-side Clinical Quality Assurance and Pharmacovigilance leadership. Candidates who add people-management exposure or a Master's degree accelerate fastest into director-track positions.

APPLICATION ADVISORY

Tailor your résumé around monitoring metrics: number of sites, visit types (PSV, SIV, IMV, COV), protocols and therapeutic areas covered, plus query and deviation resolution rates. Quantify budget size and inspection outcomes — 'supported two successful DCGI inspections with zero critical findings' lands far better than generic compliance claims. Prepare STAR stories on a difficult site escalation, a drug-supply shortfall and a protocol deviation. Revise ICH E6(R2), Indian New Drugs and Clinical Trials Rules 2019 timelines and CTRI registration. Expect scenario questions on mentoring juniors and using AI responsibly in trial documentation.
RECOMMENDED TRAINING
1/5
Clinical Research Starter Kit

Clinical Research Starter Kit

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