Manager, Clinical Data Systems

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.

Heres What Youll 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.

Heres What Youll Need (Basic Qualifications)

• 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.

Heres What Youll Bring to the Table (Preferred Qualifications)

• 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.

This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. Duties responsibilities and activities may change at any time with or without notice.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• 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

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Our Working Model

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .

-