Manager, Clinical Data Management

Job Overview:

We are seeking an experienced Manager, Data Management for our clinical research team in the biotech sector. The ideal candidate will have a strong background in clinical data management, preferably in the biotechnology or pharmaceutical industry, with proven leadership skills and the ability to work in a fast-paced, collaborative environment. The Manager, Data Management will be responsible for managing and organizing clinical research data, ensuring data integrity, and implementing data management best practices in alignment with industry regulations.

Responsibilities:

• Develop and maintain data management policies and procedures for clinical research
• Establish and enforce data standards and data quality controls for clinical research data
• Oversee the collection, processing, and storage of clinical research data
• Manage data security and access controls for clinical research data
• Develop and maintain data dictionaries and data models for clinical research
• Develop and maintain data management tools and systems for clinical research
• Collaborate with cross-functional teams, including clinical operations and biostatistics, to ensure data integrity and consistency in clinical research studies
• Train and mentor staff on data management best practices for clinical research
• Provide support and guidance to staff on data management issues in clinical research
• Stay current with industry trends and best practices in data management for clinical research
• Ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) and 21 CFR Part 11, in data management for clinical research
• Perform other duties as assigned

Qualifications:

• Bachelor's degree in a related field, such as biotechnology, clinical research, or information management
• Minimum of 5 years of experience in data management, preferably in clinical research in the biotech or pharmaceutical industry
• Strong understanding of clinical data management principles, processes, and best practices
• Experience with clinical data management tools and systems, such as Electronic Data Capture (EDC) systems
• Experience with regulatory compliance in clinical data management, including GCP and 21 CFR Part 11
• Excellent leadership and communication skills
• Strong problem-solving and analytical skills
• Ability to work in a fast-paced, collaborative environment
• Attention to detail and strong organizational skills
• Ability to prioritize and manage multiple tasks

Preferred Qualifications:

• Master's degree in a related field
• Experience managing a team of data management professionals in clinical research
• Certification in clinical data management, such as Certified Clinical Data Manager (CCDM)
• Experience with biotech-specific clinical data management tools and systems