Moderna is seeking a Senior Manager, Clinical Systems to assist in leading and organizing the clinical data management technology systems (ePRO, eConsent, IRT, EDC, 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:
Collaborate with Clinical Development, Digital, Quality, and Quality Systems to asses and identify new technologies to be utilized and implemented in support of clinical data management systems
Assess and provide insight to current/latest technologies and changes in regulatory environments, proactively enabling a cutting-edge approach to clinical data systems technology and processes
Drives 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
Oversee, support, and perform user account administration across multiple clinical data management technology platforms such as EDC, IRT, and Patient Portals
Provide oversight for a team of Clinical Data System Administrators in support of user access management and process improvement
Support technology improvement and innovation to enhance clinical data capture, management, and quality in compliance within applicable regulations and guidance
Liaises with clinical research organizations, vendors, and other third parties as necessary in support of clinical data system activities
Assist in vendor assessments and qualifications of clinical trial data collection systems for compliance with regulatory requirements
Support validations of clinical data management systems and software to ensure appropriate and compliant implementation of new or upgraded technologies
Heres What Youll Bring to the Table:
BS degree in Computer Science, Life Science or other technical field required; advanced degree desired
6+ years of applicable clinical data systems and/or relevant drug development experience; global experience and experience in drug development strongly preferred
4+ years of project management and leadership experience
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 commandof 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
Vendor management and oversight experience
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Creative, capable problem-solver
Experience in regulatory GCP inspections/audits
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary winter shut down
Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.