Manager, Clinical Data Systems

Moderna • Cambridge, MA

1d

About The Position

The Role: The candidate in this position will assist in leading and organizing the clinical data management technology systems (ePRO, eConsent, IRT, EDC, data review, etc.) strategy, in collaboration with global clinical development and preferred strategic providers, to support the timely and efficient delivery of clinical data with high quality and within an allocated budget. Here's What You’ll Do Collaborating with Digital, Quality and relevant business functions to assess and identify new technologies to be used in support of clinical data management systems. Assessing and providing insight to current/latest technologies and changes in regulatory environments, proactively enabling a cutting-edge approach to clinical data systems technology and processes. Driving creation, maintenance, and execution of clinical data system SOPs, work instructions, best practices, and standards in support of clinical data systems in a growing, dynamic organization. Overseeing, supporting, and performing user account administration across multiple clinical data management technology platforms such as EDC, data review tools, and IRT. Providing oversight for a team of Clinical Data System Administrators in support of user access management and process improvement. Supporting technology improvement and innovation to enhance clinical data capture, management, and quality in compliance within applicable regulations and guidance. Liaising with clinical research organizations, vendors, and other third parties as necessary in support of clinical data system activities. Assisting in vendor assessments and qualifications of clinical trial data collection systems for compliance with regulatory requirements. Supporting validations of clinical data management systems and software to ensure appropriate and compliant implementation of new or upgraded technologies.

Requirements

• BS degree in Computer Science, Life Science or other technical field required, advanced degree desired.
• 4+ years of applicable clinical data systems and/or relevant drug development experience; global experience and experience in drug development strongly preferred.
• 2+ years of project management and leadership experience.

Nice To Haves

• Knowledge of general clinical database programming principles, common software products, and technologies used in clinical trial data management.
• Knowledge and working experience with user account access and management in a compliant, regulated environment.
• Thorough command of FDA and ICH GCP regulations and industry standards applicable to drug development systems.
• Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy.
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Experience in regulatory GCP inspections/audits.

Responsibilities

• Collaborating with Digital, Quality and relevant business functions to assess and identify new technologies to be used in support of clinical data management systems.
• Assessing and providing insight to current/latest technologies and changes in regulatory environments, proactively enabling a cutting-edge approach to clinical data systems technology and processes.
• Driving creation, maintenance, and execution of clinical data system SOPs, work instructions, best practices, and standards in support of clinical data systems in a growing, dynamic organization.
• Overseeing, supporting, and performing user account administration across multiple clinical data management technology platforms such as EDC, data review tools, and IRT.
• Providing oversight for a team of Clinical Data System Administrators in support of user access management and process improvement.
• Supporting technology improvement and innovation to enhance clinical data capture, management, and quality in compliance within applicable regulations and guidance.
• Liaising with clinical research organizations, vendors, and other third parties as necessary in support of clinical data system activities.
• Assisting in vendor assessments and qualifications of clinical trial data collection systems for compliance with regulatory requirements.
• Supporting validations of clinical data management systems and software to ensure appropriate and compliant implementation of new or upgraded technologies.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Manager