Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Manager - Clinical Science (Medical Monitor)

Sun Pharma
Sun Pharma
0-4 years
Not Disclosed
Mumbai, India
10 April 14, 2026
Job Description
Job Type: Full Time Education: MD/DO Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager – Clinical Science (Medical Monitor) | RWE Clinical Trials | Mumbai

Company: Sun Pharma Laboratories Ltd
Location: Mumbai
Job Type: Full-Time
Work Mode: On-site
Experience: 0–4 Years
Qualification: MD (Pharmacology) or Equivalent Medical Degree


Job Overview

This is a high-impact role in clinical research and medical monitoring, focusing on Real World Evidence (RWE), clinical trial design, and safety oversight.

As a Manager – Clinical Science (Medical Monitor), you will lead end-to-end medical and scientific activities across interventional and non-interventional clinical studies, including protocol development, study execution, and safety evaluation. You will work closely with clinicians, KOLs, biostatisticians, and regulatory teams to ensure scientifically robust and compliant clinical trials.

This role is ideal for professionals aiming to build expertise in clinical development, medical monitoring, pharmacovigilance, and regulatory science.


Key Responsibilities

Clinical Trial Design & Medical Strategy

  • Develop study synopsis, protocols, and Clinical Study Reports (CSR)
  • Collaborate with KOLs and clinicians to define study endpoints and design
  • Present study proposals in regulatory and Subject Expert Committee (SEC) meetings

Medical Monitoring & Safety Oversight

  • Perform patient eligibility review via Interactive Response Technology (IRT)
  • Conduct real-time monitoring of study endpoints and safety data
  • Review Adverse Events (AE) and Serious Adverse Events (SAE)

Data Review & Study Execution

  • Work with data management teams on DMP, coding plans, and data cleaning
  • Ensure timely database lock and generation of Tables, Listings, and Figures (TLFs)
  • Collaborate with biostatisticians on sample size and Statistical Analysis Plan (SAP)

Risk Management & Compliance

  • Develop protocol-specific risk assessment and mitigation plans
  • Ensure compliance with ICH-GCP, NDCT Rules 2019, and regulatory guidelines
  • Interact with investigators and ethics committees to resolve study queries

Training, Publication & Collaboration

  • Train study teams on protocol execution and study endpoints
  • Plan and support publications (journals, abstracts, conferences)
  • Coordinate cross-functional teams across clinical research and regulatory domains

Required Skills & Qualifications

Education & Experience

  • MD (Pharmacology) or equivalent medical qualification
  • 0–4 years of experience in clinical research / medical monitoring

Technical Skills

  • Strong knowledge of clinical trial methodologies and research design
  • Expertise in ICH-GCP guidelines, NDCT Rules 2019, and ICMR guidelines
  • Understanding of pharmacovigilance, AE/SAE reporting, and risk management
  • Familiarity with SAP, TLFs, CRFs, and clinical data review processes

Core Competencies

  • Strong analytical and scientific thinking
  • Excellent communication and stakeholder management skills
  • Ability to work in cross-functional and matrix environments
  • High attention to detail with strategic mindset
  • Result-oriented with strong decision-making abilities

Perks & Benefits

  • Opportunity to work on RWE and advanced clinical research projects
  • Exposure to global clinical development and regulatory frameworks
  • Career growth in medical monitoring and clinical science leadership
  • Collaborative and innovation-driven work environment
  • Continuous learning and professional development opportunities

About the Company

Sun Pharma Laboratories Ltd is one of the leading global pharmaceutical companies, specializing in innovative drug development, clinical research, and specialty generics. With a strong focus on patient-centric healthcare and regulatory excellence, Sun Pharma plays a key role in advancing global medical treatments.


Salary / Compensation

💰 Not disclosed in the job description (Competitive industry package)


Work Mode

📍 On-site – Mumbai


Application Process

Candidates with MD Pharmacology and clinical research/medical monitoring experience can apply through the official careers portal of Sun Pharma.


Call to Action

If you want to build a career in clinical science, medical monitoring, and drug development, this is a premium opportunity.

👉 Apply now and grow in clinical trials, pharmacovigilance, RWE studies, and regulatory science.