Manager – Clinical Data Management
Company: Thermo Fisher Scientific
Department: Clinical Data Management (CDM)
Work Schedule: Monday–Friday (Standard)
Work Environment: Office-Based
Job Type: Full-Time
Experience Level
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field
Typically 5–8+ years of Clinical Data Management experience
Minimum 1+ year of people management or team leadership experience
Mid-Level Management Position
Salary
Estimated market salary: ₹15–28 LPA CTC, with experienced Clinical Data Management managers in global CROs potentially earning ₹28–35 LPA.
Role Summary
The Manager – Clinical Data Management is responsible for leading a team of Clinical Data Management professionals, overseeing project delivery, resource planning, quality compliance, and staff development. The role ensures clinical data management activities are delivered accurately, on time, within budget, and in compliance with regulatory requirements and client expectations.
Key Responsibilities
Team Leadership & People Management
Manage and mentor Clinical Data Management staff.
Conduct hiring, onboarding, and performance evaluations.
Support employee development and career growth.
Provide coaching, feedback, and training.
Approve leave requests, timesheets, and expense reports.
Project Oversight
Ensure timely delivery of Clinical Data Management projects.
Monitor project quality, timelines, and budgets.
Support portfolio teams in resolving project challenges.
Ensure client expectations are consistently met.
Resource Management
Allocate resources across projects.
Monitor team workload and utilization.
Support global resource planning and forecasting.
Collaborate with senior management on staffing strategies.
Quality & Compliance
Ensure compliance with:
SOPs
ICH-GCP Guidelines
Regulatory Requirements
Client Standards
Monitor quality metrics and project performance.
Support audit readiness and inspection preparedness.
Process Improvement
Participate in development of CDM processes and procedures.
Support implementation of best practices.
Drive operational efficiency and quality improvements.
Contribute to training programs and process standardization.
Stakeholder Management
Work closely with:
Project Managers
Clinical Operations Teams
Biostatistics Teams
Sponsors/Clients
Senior Management
Act as a subject matter expert for Data Management processes.
Required Qualifications
Education
Bachelor's Degree or equivalent qualification in:
Life Sciences
Pharmacy
Biotechnology
Clinical Research
Related disciplines
Professional Experience
5–8+ years in Clinical Data Management.
Experience managing clinical trial data across multiple studies.
At least 1 year of people management or team leadership experience.
Key Skills
Clinical Data Management (CDM)
Electronic Data Capture (EDC)
Clinical Trials
Resource Planning
Project Management
Team Leadership
Regulatory Compliance
Quality Management
Risk Management
Stakeholder Management
Training & Mentoring
Preferred Knowledge
ICH-GCP
FDA & EMA Clinical Data Standards
Clinical Trial Lifecycle
Data Cleaning & Validation
Database Lock & Close-Out
CRO Operations
Clinical Study Management
Soft Skills
Leadership & Team Development
Strategic Thinking
Communication Skills
Problem Solving
Decision Making
Client Management
Time Management
Conflict Resolution
Travel Requirement
Frequent domestic travel.
Occasional international travel.
Site visits and client meetings as required.
Ideal Candidate
A Clinical Data Management professional with strong project delivery experience, team leadership capabilities, and exposure to global clinical trials. The candidate should be comfortable managing people, resources, and client expectations while ensuring data quality and regulatory compliance.
Uttar Pradesh :
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