Study Delivery Specialist

4 weeks ago

thane, India TCS Full time
Role Description
This is a full-time on-site role as a Study Delivery Specialist located in Thane. The Study Delivery Specialist will be responsible for managing and coordinating clinical study activities, ensuring compliance with study protocols and regulations, and facilitating communication between study teams. The role will involve data entry, monitoring, and analysis, as well as assisting with study documentation and reporting.
Scope of work
Completion and maintenance of internal systems/databases/tracking tools and project plans (CSAP)
TMF Management
Supporting the study team in global study coordination activities
Budget management
Key contributor to Inspection readiness
Preparation and update of study documents and study plans
Vendor Management
Country Oversight
Risk Management
Clinical Supplies oversight and recruitment materials management
Qualifications
Candidate should be Pharma or life science graduate with 5-10 years of experience in Clinical Operations which must include 3-5 years of CRA experience.
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Strong organizational and project management skills
Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills
Quality mindset, critical sense, attention to details. Promotes a total quality culture
Good understanding of the principles of project planning & project management
Proven negotiation and influencing skills and effective at conflict resolution
Attention to detail and ability to follow protocols
Excellent communication and interpersonal skills
Proficiency in data entry and analysis
Experience in clinical research or a related field
Knowledge of regulatory requirements and guidelines
Ability to work effectively in a team environment
Tools knowledge like Microsoft office (Excel, PowerPoint, Word, Outlook, etc.)

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