Moderna is seeking an Associate Director, Data Management, Safety Processes, to develop and oversee best practices for clinical trials safety data handling, integration, reconciliation, medical coding and reporting. The role will collaborate with cross-functionally to define and implement Modernas clinical data standards for safety information acquisition, processing, and reporting. The position will report to the Director, Clinical Data Management.
Heres What Youll Do:
Work collaboratively with cross-functional stakeholders, including Safety and Pharmacovigilance, Biostatistics, Statistical ProgrammingClinical Development, Clinical Data Management & Standards and Digital for developing and implementing best and emerging practices for safety information integration, reconciliation, medical coding, and processing across all phases and therapeutic areas within Moderna
Leverage knowledge and expertise to coordinate safety information reconciliation strategy for Moderna-sponsored clinical studies; oversee the activities of DM vendors ensure deliverables are met in accordance with agreed-upon requirements
Collaborate with Data Management, Safety and Pharmacovigilance, Digital and Quality to assess new technologies and innovative solutions in improving the effectiveness, automation, and quality of safety data integration and processing
Oversee the DM-related Development Safety Update Reports preparedness and safety data deliverables across all the portfolio
Participate in SOP development governing safety data integration, processing and reconciliation; Develop, train and deploy best practices across Moderna and external partners
Keep up to date with Regulatory guidances (ICH E2A, E2B, E2F, E6, etc.) in regards to safety data management and procsses and support the implementation at Moderna
Collaborate with clinical study teams and vendors to ensure project deliverables are met, including quality data review and reporting in compliance with GCP, SOPs, and regulatory requirements
Participate in developing Data Management documentation, including the Data Management Plan, Medical Coding Plan, Safety Information Reconciliation Plan, CRF Completion Guidelines, etc.
Oversee clinical trial execution through medical coding consistency of clinical and safety system and therapeutically-aligned coding conventions
Assist in developing and automating a Standardized and Custom MedDRA Queries (SMQ and CMQ) and Customized Drug Grouping (CDG) standards library for clinical data review and decision support within studies and across TAs for trend analysis
Participate in the Clinical Data Standards Committee and act as the liaison between the cross-functional study team members to standardize data collection and reporting using regulatory guidance and safety data management best practices
Heres What Youll Bring to the Table:
Bachelors Degree in a science-based or health-related field
At least 8 years of clinical data management and/or data safety experience in the industry using multiple database management and pharmacovigilance platforms. Experience utilizing safety gateway(s) is an asset.
Medical coding experience in the industry using MedDRA and WHO Drug across multiple indications and coding platforms.
Multi-faceted background devising plans for operational challenges such as preparing data optimized for clinical data review, creating analytical tools report specifications to identify clinical and laboratory data outliers, vendor oversight, protocol deviation management, etc.
Expert knowledge of ICH/Regulatory authorities regulations and industry standards applicable to data capture and safety data management process
Cross Collaboration proficiency with other functions such as Safety and Pharmacovigilance, Biostatistics, Statistical Programming, and Safety and Medical Monitoring
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
Excellent interpersonal skills, ability to develop essential relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
Creative, capable problem-solver
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.