Senior Clinical Study Delivery Lead

2 meses atrás


São Paulo, São Paulo, Brasil Tata Consultancy Services Tempo inteiro
About the Role

We are seeking a highly skilled and experienced Senior Clinical Study Delivery Lead to join our team at Tata Consultancy Services. As a key member of our clinical study delivery team, you will be responsible for ensuring the successful delivery of clinical studies across all phases and therapeutic areas.

Key Responsibilities
  • Manage multiple competing priorities within various clinical studies with excellent planning, time management, and prioritization skills.
  • Think independently, analyze and solve problems systematically and creatively, and take a risk-based approach.
  • Develop and maintain a deep understanding of clinical trial regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
  • Work closely with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival.
  • Ensure the completeness of internal systems, databases, tracking tools, and project plans (CSAP).
  • Collaborate with internal and external partners on clinical study management activities, as agreed with the Study Delivery Lead.
  • Provide subject matter expertise across key processes and systems throughout the life cycle of the study.
Requirements
  • University degree or equivalent, preferably in medical or biological science or a discipline associated with clinical studies.
  • Relevant work experience in a pharmaceutical/scientific environment.
  • Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
  • Strong project management skills, preferably with analytical/financial skills, and good leadership skills.
  • Excellent verbal and written communication in English.
  • Excellent communication and relationship building skills, including external service provider management skills.
What We Offer
  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • A dynamic and inclusive work environment.
  • Recognition and rewards for outstanding performance.


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