Moderna is seeking a Senior Manager, Clinical Data Systems Development. This role will lead eCRF Specification design and delivery of systems and documentation to support clinical data capture and data quality adherence for Moderna Infectious Disease trials
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Lead the electronic data capture design activities and the delivery of systems and study level documentation for Infectious Disease trials.
- Collaborate with data management and cross-functional study team members to develop eCRF specifications, build and/or implement Case Report Forms (eCRFs) for clinical trials.
- Collaborate with the Moderna Clinical Data Standards Committee to define new standards for inclusion within the Moderna Global Library for eCRFs, edit checks and cross-eCRF quality checks.
- Manage and document version control for all eCRF and data quality checks specification modifications and implementations and maintains study level inspection readiness for clinical database and data quality checks documentation
- Ability to identify and troubleshoot clinical database design and maintenance issues and provide guidance to clinical data management and outsourced vendors responsible for EDC and data quality check implementation.
- Leads cross-functional study team members and participates in clinical database design User Acceptance Testing (UAT); assist Data Management in oversight of EDC builds by outsourced vendors for the resolution of findings.
- Monitors the quality of outsourced clinical database clinical biomarker data deliverables for Infectious Disease trials; anticipates and mitigates the risks and measures the performance through metrics and KPIs
- Works with cross-functional team members and external vendors to develops best practices for clinical database design, testing and UAT.
- Ensures achievement of clinical database creation and modification deliverables and milestones in coordination with outsourced vendors, data management and cross functional team members for Infectious Disease trials.
- Lead/participate in the implementation and adoption of innovative clinical data management systems (CDMS) for data capture and cleaning.
- Lead/contribute to/participate in Moderna Clinical Data Management Initiatives, Innovation, and Implementation. Support adoption iof new capabilities and business process
- Participate in the development and optimization of clinical data management data management SOPs, processes, and initiatives for clinical database design and implementation and clinical data standards management.
- Collaborates with the cross-functional study team to define and implement clinical data management standards for data collection, capture and cleaning utilized across the Infectious Disease TA
- Responsible contributing to the development of Data Management documentation including Data Management Plan; Data Validation Specifications, Data Handling Guidelines; etc for the Infectious Disease TA.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Bachelor's Degree in an engineering, computer science or health science field
- 5+ years of clinical data management experience in industry, with experience across indications and relational databases and experience using multiple clinical data management systems
- Experience with leading, implementing or adopting new technologies, systems or processes
- Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
- Prior experience with data transfers or management
- Thorough command of FDA and ICH GCP regulations and industry standards applicable to data capture and data management process
- 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
- Creative, capable problem-solver
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
- 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 year-end shutdown
• 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.About Moderna
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.