Data Scientist developing AI agents and advanced analytics solutions for Ciena. Focused on machine learning, generative AI, and delivering business value through intelligent data - driven tools.
About the role
- Clinical Data Manager overseeing comprehensive data management activities in clinical trials. Ensuring regulatory compliance and data quality while collaborating with clients and teams.
Responsibilities
- Lead comprehensive data management activities for multiple clinical trials, ensuring regulatory compliance and data quality.
- Plan, develop, test, and validate clinical databases and EDC systems to meet trial needs.
- Collaborate with clients and cross-functional teams on study design, eCRF design, and data cleaning.
- Monitor and ensure data quality, accuracy, and timely database entries from study sites.
- Manage external vendors to deliver quality services within project timelines.
- Maintain regular communication with clients to update on milestones and progress.
- Ensure adherence to GCP, ICH, and regulatory requirements, supporting audits and inspections.
- Proactively track study timelines, managing risks and deviations effectively.
- Contribute to process improvement by developing systems, SOPs, and guidance documents.
- Support business development activities, including preparing presentations and bid defense materials.
Requirements
- Bachelor’s Degree in a related field
- Knowledge of GCP and ICH guidelines
- Experience in data review and cleaning activities
- Proficiency in MS Office suite and data capture systems
- Experience in clinical research, preferably with pharmaceutical or medical device companies, hospitals or CROs
- Familiarity with statistics, programming, and field monitoring
- Effective communication skills and leadership skills
Benefits
- Medical, dental, and vision insurance, FSA, HSA
- Voluntary short-term and long-term disability insurance
- Voluntary life insurance
- 401K safe harbor plan and company match
- Paid vacation, holiday, and sick time
- Paid maternity & paternity leave
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