Associate Director Clinical Data Management -
Salary: $150,000/yr - $160,000/yr
Location: Palo Alto, California
Embark on an extraordinary career journey with a distinguished biopharmaceutical company that is revolutionizing the field of genetic medicine. Our client is driven by an unwavering commitment to develop groundbreaking therapies that target unmet medical needs. With a unique approach, they establish subsidiary companies dedicated to specific genetic diseases, optimizing resource allocation and fostering unparalleled efficiency. Backed by a diverse portfolio encompassing small molecules, gene therapies, and RNA-based treatments, our client's relentless pursuit of success propels them to the forefront of innovation in genetic medicine.
We are seeking an experienced Associate Director of Clinical Data Management to oversee all aspects of clinical trial data management. In this role, you will lead a team, ensuring data integrity, accuracy, and compliance with regulatory standards. Collaborating with cross-functional teams, you will contribute to protocol development, streamline data collection processes, and manage vendor relationships. The ideal candidate has a strong background in clinical data management, excellent communication skills, and a track record of successful leadership. Join us and make a significant impact in genetic medicine.
- Provide strategic leadership and guidance to a team of data management professionals, fostering a high-performance culture and ensuring efficient operations.
- Oversee all aspects of clinical data management activities, including database design, data validation, data cleaning, and database lock, to ensure data integrity and accuracy.
- Collaborate with cross-functional teams to contribute to the development and review of clinical trial protocols, ensuring data management requirements are incorporated.
- Ensure compliance with regulatory requirements, industry standards, and data management best practices, implementing quality control measures to maintain data accuracy and consistency.
- Select, onboard, and manage external vendors, such as contract research organizations (CROs) and data management service providers, ensuring their adherence to timelines, deliverables, and quality standards.
- Continuously evaluate and optimize data management processes, identifying areas for efficiency enhancement, implementing innovative solutions, and promoting best practices across the organization.
- Collaborate with clinical operations, biostatistics, regulatory affairs, and other departments to align data management activities with study objectives, timelines, and regulatory requirements.
- Identify potential risks and issues related to data management, develop risk mitigation strategies, and implement corrective actions when necessary.
- Bachelors or higher preferably in math, science or health-related field with a minimum of 5 years of experience in clinical data management across phase 1- 3 clinical trials. At least 2 years of overall experience require acting as a study lead data manager
- Experience in regulatory GCP inspections/audits is a plus
- Comprehensive experience working with clinical database systems
- Working knowledge of CDISC including CDASH, TAUG, and SDTM as well as data privacy regulations e.g. GDPR
- Successfully manage clinical data management vendors, contractors, and service providers for program - deliverables
- Managerial and oversight experience with junior-level data managers preferred
- Able to work in a fast-paced and dynamic environment while effectively managing multiple projects which may have changing priorities
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors