Sr. Manager, Clinical Data Management, Infectious Disease
Nov 15, 2023
200 Technology Square - Cambridge - USA - MA
Moderna is seeking a Senior Manager, 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 at Moderna
Here’s What You’ll Do:
Represents the Moderna data management function for clinical studies within a Therapeutic Area or program and ensures aligned expectations between external data vendors and the Moderna cross-functional stakeholders for all data related deliverables
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;
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
Here’s What You’ll Bring to the Table:
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 1-3 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
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
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
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!
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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)