Clinical Data Services Specialist (Team Lead / Consultant)
Company: Accenture
Job ID: AIOC-S01649819
Location: Mumbai
Employment Type: Full Time
Department: Clinical Data Services – Clinical Data Management
Qualification: Master of Pharmacy (M.Pharm)
Experience: 7–11 Years
About the Role
Accenture is seeking an experienced Clinical Data Services Specialist to lead Clinical Data Management (CDM) activities within its Life Sciences R&D practice. This role involves end-to-end management of clinical data projects, oversight of study deliverables, stakeholder management, and ensuring regulatory compliance throughout the clinical trial lifecycle.
The position is suitable for professionals with strong Clinical Data Management expertise, project leadership experience, and exposure to Medidata RAVE or similar EDC platforms.
Key Responsibilities
Lead Clinical Data Management projects across the complete study lifecycle.
Manage study start-up, conduct, and close-out activities.
Oversee project timelines, quality metrics, and deliverables.
Coordinate with sponsors, CROs, biostatistics, clinical operations, and regulatory teams.
Ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
Review data management plans, edit checks, and study documentation.
Monitor study progress and proactively resolve operational challenges.
Support database build reviews, data cleaning activities, and database lock processes.
Drive process improvements and best practices across projects.
Provide guidance and mentorship to junior CDM team members.
Required Skills
Clinical Data Management (CDM)
Clinical Trial Lifecycle Management
Project Management
Medidata RAVE EDC (Preferred)
Data Review & Validation
Database Lock Activities
Stakeholder Management
ICH-GCP Knowledge
Clinical Documentation Management
Microsoft Excel, Word & PowerPoint
Problem Solving & Analytical Skills
Preferred Experience
7+ years of Clinical Data Management experience.
Experience managing global clinical studies.
Hands-on exposure to Medidata RAVE or other EDC platforms.
Leadership experience in cross-functional project environments.
Experience handling study start-up, conduct, and close-out phases.
Knowledge of regulatory guidelines and clinical documentation requirements.
Ideal Candidate Profile
M.Pharm professional with extensive CDM experience.
Strong project leadership and stakeholder management capabilities.
Ability to manage multiple studies and priorities simultaneously.
Comfortable working in fast-paced global environments.
Detail-oriented with excellent communication and organizational skills.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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