Senior Manager - Clinical Data Management - Pharma

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.