Lead - Clinical Research, (Rwe) Medical Affairs

Sun Pharma

7+ years

Not Disclosed

Mumbai, India

Openings: -10 June 15, 2026

Job Description

Job Type: Full Time Education: Bachelor’s or Master’s degree in Technical , Life Sciences , Biology, Biochemistry, Molecular Biology Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, 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

Clinical Research Operations Manager / Medical Affairs Manager

Role Overview

The role is responsible for planning, managing, and overseeing non-regulatory clinical studies conducted by Medical Affairs, including interventional studies, observational studies, registries, patient-reported outcome (PRO) studies, EMR studies, and Investigator-Initiated Studies (IIS). The position ensures compliance with regulatory requirements, GCP standards, stakeholder management, vendor oversight, and team development.

Key Responsibility Areas

1. Common Process Management

Study Governance & Compliance

Develop, review, and update SOPs and Work Instructions for:
- Non-regulatory interventional studies
- Observational studies
- Cooperative group studies
- Registries
- PRO studies
- EMR studies
- Investigator-Initiated Studies (IIS)
Ensure compliance with:
- ICH-GCP guidelines
- Trial protocols
- Applicable regulations
- Internal administrative requirements

Study Planning & Tracking

Develop trackers and monitoring systems to track study execution.
Create daily management matrices for study oversight.
Monitor study progress and ensure adherence to project timelines.
Identify, evaluate, and resolve study-related issues.

Investigator-Initiated Studies (IIS)

Evaluate IIS proposals received from external stakeholders.
Facilitate review and approval processes as per IIS SOPs.
Coordinate with Therapeutic Area (TA) Medical Leads and Advisors.

Documentation & Trial Management

Review and manage:
- Clinical Trial Protocols
- Case Report Forms (CRFs)
- Patient Diaries
- Informed Consent Documents (ICDs)
- Investigator Brochures (IBs)
- Serious Adverse Reports (SARs)
- Clinical Study Reports (CSRs)
- SAE Narratives
- Individual Case Safety Reports (ICSRs)
Maintain and update Trial Master Files (TMF).
Ensure document archival according to GCP and regulatory requirements.

Budget & Stakeholder Management

Prepare and manage study budgets.
Coordinate with internal and external stakeholders.
Act as the primary contact for study-related activities.

Risk & Quality Management

Conduct risk assessments and mitigation planning.
Develop corrective and preventive action (CAPA) plans.
Handle audits and inspections.
Maintain monthly dashboard reporting for study progress.

2. CRO Managed Studies

CRO Selection & Oversight

Identify, evaluate, and manage Contract Research Organizations (CROs).
Conduct bi-annual CRO assessments.
Review CRO SOPs, systems, and operational processes.

Site & Investigator Management

Identify investigators and study sites in collaboration with CROs.
Support study agreements and financial contracts.

Regulatory Coordination

Prepare and review regulatory submission documents.
Coordinate with:
- Medical Affairs
- Regulatory Affairs
- Quality Assurance (QA)
- Other internal stakeholders

Safety Reporting

Ensure timely reporting of:
- Serious Adverse Events (SAEs)
- Suspected Unexpected Serious Adverse Reactions (SUSARs)

Vendor Management

Manage vendors according to organizational policies.
Ensure CRO training on Pharmacovigilance (PV) practices.

Clinical Supply Management

Plan investigational product procurement and distribution.
Coordinate study material logistics.

3. In-House Managed Studies

Study Start-Up Activities

Conduct site feasibility assessments.
Identify and select investigators and sites.
Develop study budgets.
Execute confidentiality and study contracts.

Ethics & Regulatory Approvals

Prepare and submit Ethics Committee applications.
Obtain required approvals for study initiation.

Investigator & Site Management

Organize Investigator Meetings.
Train investigators and site staff on:
- Study protocols
- Study procedures
- GCP requirements

Clinical Operations

Site initiation, monitoring, and close-out visits.
Ensure participant recruitment targets are achieved.
Manage study data quality and integrity.

Monitoring Activities

Conduct:
- Source Data Verification (SDV)
- Informed Consent Review
- CRF Review
- Drug Accountability Checks
- Adverse Event Reviews

Safety Management

Ensure timely SAE and SUSAR reporting.
Coordinate safety communication with investigators and sites.

Data Management & Analysis

Coordinate with internal teams or CRO partners for:
- Data management
- Statistical analysis
- Statistical reports
Lead data query resolution processes.

Budget & Financial Management

Manage clinical trial budgets.
Maintain study financial records and accounts.

Risk Management

Identify site-level risks.
Implement CAPA plans for underperforming sites.

People Development & Leadership

Talent Management

Recruit and retain high-quality clinical research professionals.
Develop Individual Development Plans (IDPs).
Support employee growth and career development.

Team Performance

Drive team performance metrics.
Foster collaboration across Medical Affairs and cross-functional teams.

Stakeholder Management

Build strong relationships with:
- Internal stakeholders
- External investigators
- CRO partners
- Regulatory bodies

Experience Requirements

Required

More than 7 years of experience in Medical Affairs or Clinical Research Operations.
Experience managing Real-World Evidence (RWE) studies.
Training in:
- Clinical Trial Methodology
- Research Design
- ICH-GCP Guidelines

Preferred

Experience in matrix organizations.
Experience managing teams and people.

Regulatory & Technical Knowledge

Strong understanding of:

ICH-GCP Guidelines
ICMR Guidelines 2017
Drugs & Cosmetics Act related to Clinical Trials
Clinical Research Methodologies
Pharmacovigilance Processes
Regulatory Submission Requirements
Risk Management & CAPA Processes

Core Competencies

Functional Competencies

Clinical Research Operations
Clinical Trial Management
Regulatory Compliance
Vendor & CRO Management
Budget Management
Risk Assessment & Mitigation

Leadership Competencies

Strategic Thinking
Team Leadership
Stakeholder Management
Decision Making
Performance Management

Behavioral Competencies

Integrity and Ethics
Strong Analytical Skills
Attention to Detail
Results Orientation
Intellectual Curiosity
Adaptability in Matrix Organizations
Sense of Urgency
Collaboration & Teamwork
Excellent Communication and Interpersonal Skills

Work Location & Travel

Primary Work Location: Office-based role (Mumbai)
Travel Requirement: Approximately 4–5 days of travel per month outside Mumbai for study oversight, investigator meetings, site monitoring, and stakeholder interactions.

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