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

Clinical Data Manager

NovoTech
6-10 years
preferred by company
PAN-India, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding

Job Title: Clinical Data Manager

Location: India
Job Type: Full-Time
Experience Required: 6–10 Years (Freshers are not eligible)
Industry: Clinical Data Management / Clinical Research / CRO / Pharmaceuticals / Biotechnology / Life Sciences
Department: Data Management / Clinical Operations

About the Role
We are seeking an experienced and strategically driven Clinical Data Manager to lead end-to-end clinical data management activities for global clinical trials within a dynamic CRO environment. This senior-level opportunity is ideal for professionals with expertise in clinical data management, electronic data capture (EDC), database design, data validation, GCDMP compliance, clinical trial data quality, and cross-functional project leadership.

The ideal candidate will oversee all aspects of clinical trial data management, ensuring high-quality, compliant, and efficient delivery of data management services aligned with study protocols, client expectations, regulatory requirements, and operational excellence standards.

This opportunity is highly suited for experienced clinical data professionals seeking leadership growth in global clinical trial operations.

Key Responsibilities

End-to-End Clinical Data Management Leadership

  • Lead complete clinical data management activities for assigned global clinical trials from study startup through database lock and closeout.
  • Manage data management execution in alignment with study protocols, project plans, client requirements, SOPs, and Good Clinical Data Management Practices (GCDMP).
  • Ensure high-quality clinical data delivery supporting regulatory submissions and study decision-making.

Clinical Database Design & Data Validation

  • Oversee design, review, and optimization of clinical databases, validation rules, edit checks, consistency checks, and data collection workflows.
  • Ensure database structures align with protocol requirements, study design, and data quality objectives.
  • Support operation and oversight of clinical data management systems for efficient trial data capture and management.

Data Cleaning, Query Management & Data Quality Control

  • Lead all data cleaning, discrepancy management, validation review, and query resolution activities across clinical studies.
  • Ensure timely identification and resolution of data inconsistencies, missing information, and quality issues.
  • Maintain robust data integrity, audit readiness, and quality governance standards throughout the study lifecycle.

Project Management & Cross-Functional Study Leadership

  • Act as the primary clinical data management lead within project teams, collaborating with Project Managers, Clinical Operations, Biostatistics, Regulatory Affairs, Medical Monitoring, and sponsor stakeholders.
  • Participate in project meetings, study governance discussions, and operational planning activities.
  • May serve as Project Manager for standalone clinical data management engagements where required.

Data Management Planning & Documentation Governance

  • Develop, maintain, and oversee key clinical data management documentation including:
    • Data Management Plans (DMPs)
    • Validation specifications
    • Data review plans
    • Query management workflows
    • Study documentation and operational records
  • Ensure documentation aligns with internal standards, client expectations, and regulatory compliance requirements.

Client & Vendor Stakeholder Management

  • Serve as a key liaison between internal teams, clients, monitoring staff, and external service providers.
  • Support effective communication, issue management, project alignment, and operational transparency across stakeholders.
  • Ensure client deliverables meet agreed timelines, scope, and quality expectations.

Feasibility, Business Development & Strategic Support

  • Assess study feasibility from a data management perspective and identify operational risks, mitigation plans, and delivery contingencies.
  • Support RFP responses, proposal development, business development initiatives, and solution planning in collaboration with commercial and clinical teams.
  • Contribute expert data management input to strategic organizational initiatives.

Financial & Scope Management

  • Support project financial forecasting, scope management, monthly project financial reviews, and resource planning.
  • Identify scope changes proactively and ensure operational alignment with contractual requirements.

Leadership, Mentorship & Team Development

  • Provide supervision, mentorship, and training support for junior clinical data managers, contract staff, and project teams.
  • Promote a culture of quality, accountability, collaboration, and continuous improvement.
  • Support development of team capabilities and operational excellence practices.

Process Improvement & Innovation

  • Identify opportunities to improve clinical data workflows, operational efficiency, quality systems, and internal processes.
  • Contribute to internal IT initiatives, data process innovation, and organizational transformation projects where relevant.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, Biomedical Sciences, Biotechnology, Healthcare, or related scientific disciplines.
  • Minimum 6–10 years of relevant clinical data management experience within CROs, pharmaceutical companies, biotechnology organizations, or clinical research environments.
  • Strong expertise in clinical data management systems, database design, EDC workflows, query management, data cleaning, and GCDMP compliance.
  • Proven experience managing global clinical trial data operations across multiple stakeholders.
  • Strong understanding of ICH-GCP, regulatory requirements, clinical trial workflows, and quality governance expectations.
  • Experience with client-facing project management and operational leadership preferred.
  • Excellent analytical thinking, documentation, stakeholder management, and decision-making skills.