Sr. Manager, Clinical Data Standards
Reporting to the Director, Clinical Data Standards and Integration, the Senior Manager, Clinical Data Standards will be responsible for supporting the initiative to utilize internal and external partners to develop and maintain Moderna Clinical Data Standards Governance. Collaborate cross-functionally to ensure proper utilization of the clinical data standards and adherence of associated standards processes across clinical development and across the Moderna portfolio.
Here’s What You’ll Do:
Support the Data Standards lead in developing core CRF standards in a repository tool which includes ODM terminology and allows for visual presentation to stakeholders prior to CRF standards acceptance and EDC adoption.
Develops Business rules within the metadata to align to Therapeutic Area Standards
Supports relationships across the Moderna organization and with CRO partners in support of the standards vision and implementation to support data alignment across functional areas and within each therapeutic area.
Develops and manages standard edit check specifications and process for UAT testing of Global Library
Implement and perform versioning; develop global standard CDASH case report form library and code lists
Ensures compliance to the Moderna Global Library, developing reports utilizing external partners
Analyze data standards adherence and define means to improve CDASH case report form library
Support an integrated rollout strategy for implementation of new processes, standards, and/or technologies to ensure clear scope, comprehensive communication, training, assessment, and continued improvement opportunities for internal personnel and outsourced provider(s).
Consult with CRO and vendor partners to establish current and forward-looking standardized electronic Case Report Forms (eCRFs) and data checks.
Develops training strategy and ensures consistent training program for standards for internal stakeholder and external partners
Monitor releases of Standard Development Organizations (e.g. CDISC)
Participates in clinical data standards communication, newsletters etc. to support data standards awareness, adoption, utilization and compliance.
Here’s What You’ll Bring to the Table:
Bachelor’s Degree in computer science or a science-based subject is highly preferred
At least 5 years of data science, data analysis or clinical data management experience in industry, with experience across indications and EDC platforms
Deep understanding of drug development and biopharmaceutical Industry required
Extensive knowledge of standards, regulatory and drug submission requirements and current regulatory trends Including global landscape; including thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
Strong management skills, and ability to effectively lead and collaborate with various business functions
Demonstrates leadership, problem solving, conflict resolution, and team building skills
Demonstrated ability establish effective business relationships with external stakeholders, including implementing process change at a vendor
Proven ability to manage multiple competing priorities
Strong technical skills across data platforms
Experienced with CDISC (CDASH, SDTM, ODM.XML) and other industry standards
Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology.
Experience with Spotfire or other data visualization software
Outstanding verbal and written communication skills, in addition to excellent organizational skills
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 person’s 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.#LI-JM2