Moderna is seeking an Associate Director, Clinical Data Management, Infectious Disease to lead clinical data management efforts and initiatives for the Infectious Disease Therapeutic Area as well as support the oversight of data management vendors and data handling. This role will report to the Director, Clinical Data Management, Infectious Disease at Moderna in Cambridge, MA.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Represents the Moderna data management function for a Therapeutic Area or program and ensures aligned expectations between external data vendors and the Moderna cross-functional stakeholders for all data related deliverables
- Responsible for data vendor oversight activities including consistency, quality and timeliness of all deliverables across a therapeutic area or program in compliance with GCP, SOP and regulatory requirements;
- Ensures achievement of data management deliverables and milestones in coordination with cross functional team members including: Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management and Pharmacovigilance
- Responsible for leading/overseeing the design, creating and testing and implementation of data capture tools and integrations for data capture, data processing, coding and validation in accordance with the data collection requirements as defined in the clinical protocol, in alignment with industry best practice guidelines and enforcement of Moderna data standards and processes;
- Responsible for authoring or overseeing the development of all Data Management documentation including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, Data Transfer Specifications; etc.
- Responsible for leading the cross-functional data review for a program or therapeutic area; support cross-functional team with tools and processes to successfully enable and achieve cross-functional data review
- Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements; Review data analysis listings and report on performance and quality; review clinical data within studies and across for trend analysis
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
- Contribute to/participate in Moderna Data Management Initiatives and Innovation Implementation
- May participate in the development and optimization of data management SOPs, processes and initiatives.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Bachelor's Degree in an analytical or health-related field
- 8+ years of clinical data management experience in industry, with experience across indications and relational databases and experience using multiple clinical data management systems
- Phase 1-IV clinical development experience
- Multi-faceted background devising plans for operational challenges such as site EDC training, preparing cohorts for data review in dose escalation, vendor oversight, protocol deviation management, data cleaning, etc.
- 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
- Successful experience managing vendor relationships
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- 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 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.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.