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Associate Manager Clinical Affairs
Stryker Corporation
Full time
6+ years
Not Disclosed
Gurugram, India
Post Date: Feb 20, 2024
End Date: Apr 20, 2024
Expired
6+ years
Not Disclosed
Gurugram, India
Post Date:Feb 20, 2024
End Date: Apr 20, 2024
Skills:
clinical research
Regulatory Affairs
Management
Job Description:
Responsibilities
Creating and writing trial protocols, and presenting these to the internal/external committee.
Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
Ordering, tracking, and managing trial materials.
Conducting regular site visits, coordinating project meetings, and writing visit reports.
Implementing action plans for sites not meeting expectations.
Liaising with regulatory authorities wherever required
Ensuring compliance with internal SOPs and local regulations, and ICH and GCP guidelines.
Other tasks and responsibilities as needed.
Responsible for developing close relationship with key customers across India to understand clinical needs and proposed trail ideas
Follow up with customer on a regular intervals during protocol development, execution, report generation and publication
Ensures customer and all related staff understands final protocol and meets required timelines
Ensures protocol is written as per global guidance and customers proposed plan
Creates content for publication of report/article/clinical trial after data is fully analyzed and is ready for publication
Qualification & Experience
Master’s degree in biological science or a related field.
Min 6 plus years minimum experience in clinical research.
Knowledge of the health care industry, terminology, and practices.
Knowledge of India clinical trial regulations and their implementation.
Job Overview
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Salary
Not Disclosed
Role
Manager
Area of Practice
Medical Affairs
Experience
6+ years
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