Study Delivery Specialists

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



Apply only if you have experience on above activities and having qualifications as below.


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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