Senior Manager - Clinical Data Management - Pharma
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Senior Manager - Clinical Data Management - Pharma
Tekskills India Private LimitedThane, India
28 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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Manager Data Management • Thane, India
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