Sr. Associate – Clinical Projects Coordinator
Company: Alcon
Location: Bangalore, India
Job Type: Full-time
Work Model: Remote type not applicable (office-based/onsite hybrid as per project needs)
Job Overview
The Senior Associate – Clinical Projects Coordinator supports clinical data management and clinical operations activities within the R&D organization. The role focuses on planning, execution, and reporting of clinical studies in ophthalmology and vision science, ensuring compliance, data integrity, and high-quality evidence generation for medical device development and post-market surveillance.
Key Responsibilities
A. Clinical Data Management & Processing
Process, organize, and maintain clinical study data and records
Ensure accuracy, consistency, and timely availability of clinical data
Perform data entry and source-to-CRF verification
Conduct routine and ad-hoc data quality checks
B. Clinical Study Support
Assist in planning, conduct, and reporting of clinical studies
Review study documents including:
Clinical protocols
Statistical Analysis Plans (SAPs)
Clinical study reports
Ensure scientific rigor, data integrity, and regulatory compliance
C. CRF Design & Data Tools
Support development of Case Report Forms (CRFs)
Assist in creation of study-specific data capture tools
Contribute to structured clinical data collection systems
D. Scientific Analysis & Reporting
Review and analyze clinical study data and published literature
Prepare:
Literature reviews
Narrative scientific summaries
Slide decks and scientific presentations
Support publications (abstracts, posters, peer-reviewed manuscripts)
E. Clinical Operations Coordination
Coordinate with investigators for:
Clinical Trial Agreements (CTA)
CTRI registration
IRB/IEC submissions
Study equipment training
Monitor study progress and compliance
Track study milestones and payment processes
F. Logistics & Study Support
Manage ancillary supply logistics
Support import, transportation, and storage of study materials
Assist operational execution of clinical studies
G. Compliance & Quality Assurance
Follow GxP requirements and SOPs
Ensure complete and accurate documentation
Complete required compliance and training activities
Maintain audit-ready study documentation
H. Competitive Intelligence (CI)
Collect and analyze competitive intelligence from:
Conferences (optometry/ophthalmology)
Scientific journals
Internal CI systems
Prepare structured CI reports and summaries
Core Skills Required
Clinical data management
CRF design and data verification
Clinical trial operations support
Data quality checks and validation
Scientific writing and literature review
Understanding of GCP and ISO standards
Basic biostatistics knowledge
Microsoft Excel and PowerPoint (advanced preferred)
Data visualization and reporting
Therapeutic / Domain Expertise
Ophthalmology / Optometry / Vision Science
Medical device clinical research
Intraocular lenses and optical systems (preferred)
Post-market surveillance and device lifecycle knowledge
Soft Skills
Strong scientific communication
Analytical thinking and attention to detail
Ability to manage multiple priorities
Collaboration with cross-functional and external stakeholders
Time management in fast-paced environment
Work Environment
Medical device clinical research setting
Combination of clinical operations + data management + scientific analysis
High documentation and compliance focus (GxP environment)
Interaction with global research and clinical teams
Career Positioning Insight
This role sits at the intersection of:
Clinical Data Management
Clinical Operations
Medical Writing / Scientific Communication
Medical Device Research (ophthalmology)
It typically leads to roles such as:
Clinical Data Manager
Clinical Project Manager
Clinical Research Scientist (Medical Devices)
Medical Affairs / Evidence Generation roles
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