Clinical Data Services Associate Manager
Job Title: Clinical Data Services Associate Manager
Company: Accenture
Location: Bengaluru, India
Employment Type: Full-Time
Experience Required: 10–14 Years
Function: Clinical Data Management (CDM) / Clinical Data Operations
Industry: Life Sciences / Clinical Research / Pharmaceutical Services
Position Overview
Accenture is seeking an experienced Clinical Data Services Associate Manager to lead and manage clinical data operations across global clinical research programs. This role is responsible for overseeing end-to-end clinical data management activities, ensuring high-quality, compliant, and timely delivery of clinical trial data to support drug development and regulatory submissions.
The successful candidate will serve as a key liaison between study teams, sponsors, and cross-functional stakeholders while driving operational excellence across multiple clinical studies. The role requires strong project management capabilities, leadership skills, and deep expertise in clinical data management processes throughout the clinical trial lifecycle.
Key Responsibilities
Clinical Data Management Leadership
Lead end-to-end clinical data management activities across assigned clinical studies.
Oversee study start-up, conduct, and database close-out activities.
Ensure clinical trial data is collected, validated, reconciled, and delivered according to project timelines and quality standards.
Act as the primary point of contact for study teams and sponsors regarding clinical data management activities.
Clinical Data Operations
Manage all aspects of clinical data operations, including:
Data Collection
Data Validation
Data Cleaning
Query Management
Data Review
Database Lock Activities
Ensure data integrity, consistency, and regulatory compliance throughout the study lifecycle.
Monitor key data management metrics and project milestones.
Data Review & Reconciliation
Lead and oversee:
SAE Reconciliation
External Data Reconciliation
Laboratory Data Review
Protocol Deviation Identification
Data Cleaning Activities
Ensure timely resolution of discrepancies and data issues.
Coordinate with safety, clinical operations, and vendor teams for reconciliation activities.
Project & Portfolio Management
Manage multiple clinical studies and study portfolios simultaneously.
Develop project plans, timelines, resource allocation strategies, and risk mitigation plans.
Track project deliverables and proactively address operational challenges.
Ensure study milestones are achieved within budget and timelines.
Stakeholder & Client Management
Build and maintain strong relationships with:
Sponsors
Clinical Operations Teams
Biostatistics Teams
Regulatory Teams
Pharmacovigilance Teams
External Vendors
Serve as the primary escalation point for data management issues.
Provide regular project status updates and strategic recommendations to stakeholders.
Team Leadership & People Management
Lead, mentor, and develop clinical data management teams.
Manage medium-sized project teams and support team performance initiatives.
Provide guidance on complex clinical data management activities.
Support talent development, training, and knowledge-sharing initiatives.
Quality & Compliance
Ensure compliance with:
ICH-GCP Guidelines
FDA Regulations
EMA Requirements
CDISC Standards
Company SOPs
Industry Best Practices
Support audit and inspection readiness activities.
Participate in quality reviews and process improvement initiatives.
Process Improvement & Innovation
Identify opportunities to improve operational efficiency and data quality.
Contribute to standardization and optimization of clinical data management processes.
Support implementation of new technologies, systems, and best practices.
Drive continuous improvement initiatives across clinical data operations.
Required Qualifications
Education
Mandatory
Bachelor’s Degree in:
Engineering (BE/B.Tech)
Life Sciences
Pharmacy
Biotechnology
Biomedical Sciences
Computer Science
Related Scientific Disciplines
Preferred
Master’s Degree in Life Sciences, Clinical Research, Data Management, or related field.
Uttar Pradesh :
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