Lead Clinical Data Manager
2 weeks ago
Everest Clinical Research Services Inc. is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Key Accountabilities:
- Lead and manage clinical trial data management activities throughout the entire project lifecycle.
- Develop and implement data management plans, ensuring compliance with regulatory guidelines and industry standards.
- Oversee data collection, cleaning, validation, and reporting processes, ensuring accuracy and integrity of clinical trial data.
- Collaborate with cross-functional teams, including study investigators, statisticians, and project managers, to ensure seamless data flow and timely delivery of results.
- Provide guidance and training to data management staff on best practices and industry standards.
- Contribute to the development and improvement of data management processes and systems.
Qualifications and Experience:
- Master's degree or Bachelor's degree in a related field, such as healthcare informatics, biostatistics, or computer science.
- Extensive experience (10+ years) in clinical data management within the pharmaceutical or biotechnology industry.
- In-depth understanding of clinical trial regulations, guidelines, and industry standards (e.g., ICH GCP, FDA 21 CFR Part 11).
- Proven leadership skills with the ability to manage and motivate a team of data management professionals.
- Excellent communication, interpersonal, and problem-solving skills.
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