Moderna is seeking a Senior Manager, Clinical Data Management to work across its programs. This position will initiate best practices and lead clinical data management initiatives across the ventures as well as support the oversight of data management vendors and data handling. This role will report to the Director, Clinical Data Management at Moderna
Here's What You'll Do:
Perform data management oversight activities in support of Moderna clinical studies; oversee the activities of CRO DM counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance to quality
Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements
Participate in the development of all Data Management documentation including the Data Management Plan, CRF Completion Guidelines, Data Validation Specification, Data Transfer Specifications, etc.
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
Perform thorough development testing of the eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable
Participate in the Data Standards Committee and act as the liaison between the study team members Rare Diseases to standardize data collection and reporting
Here's What You'll Bring to the Table:
Bachelor's Degree in a science-based subject expertise.
At least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms
Early and late 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.
Cross Collaboration proficiency with other functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Outstanding verbal and written communication skills, in addition to excellent organizational skills
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 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!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
