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Senior Manager - Clinical Data Management - Pharma

Senior Manager - Clinical Data Management - Pharma

Tekskills India Private LimitedNavi Mumbai, India
30+ days ago
Job description

Key Responsibilities

  • Clinical Data Management Oversight : You will be responsible for the oversight of all data management activities, ensuring they meet the obligations of ICH-GCP and our company's scope of work. Your primary goal is to maximize effectiveness and stay within budget.
  • Problem-Solving & Expertise : You will provide and enable solutions for complex problems, serving as a key expert for all aspects of clinical data management. You'll lead cross-functional teams to perform proper data reviews and provide guidance on CDISC standards.
  • Project Leadership : You will demonstrate strong project management skills by overseeing data management activities for large drug development programs, handling multiple programs simultaneously, and ensuring the team delivers on time.
  • Regulatory Compliance : You will apply your expert knowledge of FDA and ICH regulations and industry standards to data capture and data management processes.

Technical Skills

  • Data Management & Technology : Extensive experience in data management and the drug development process.
  • Clinical Database : Strong knowledge of Clinical Database Programming Overview and study setup.
  • CDISC Standards : Expert knowledge of CDISC standards and their application.
  • Regulatory Knowledge : Deep understanding of FDA and ICH regulations.
  • Clinical Trial Documents : Solid understanding of key clinical trial documents such as protocols, statistical analysis plans, CRFs, and study reports.

    • Experience & Education

  • Experience : A minimum of 8-10 years of total experience, with at least 7 years of relevant experience in clinical data management and / or the drug development process. Proven track record of managing large drug development programs.
  • Experience with all phases of development and NDA / CTD submissions is preferred.
  • Education : A Bachelor's degree in a health-related, life science area or technology-related field is mandatory, along with an MBA.

    • (ref : iimjobs.com)

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