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Associate Director, Clinical Data Management, Infectious Disease
4 months ago
The Role:
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 ModernaHere's What You'll Do:Represents the Moderna data management function for Infectious Disease trials and ensures aligned expectations between external data vendors and the Moderna cross-functional stakeholders for all data related deliverablesResponsible for data vendor oversight activities including consistency, quality and timeliness of all deliverables across Infectious Disease 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 PharmacovigilanceResponsible for leading/overseeing the design, creation and testing and implementation of data capture tools and integrations for data capture, data processing, medical 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 leading/contributing to or overseeing the development of all Clinical 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 reviewLead and manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements; lead and participate in clinical data review and report on performance and quality; review clinical data within studies and across for trend analysis.
Lead cross-functional data review meetings including internal and external study team members; and ensure alignment of data delivery strategy for Infectious Disease trials.
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents for Infectious Disease trials and ensure inspection readiness for data management Contribute to/participate in Moderna Data Management Initiatives and Innovation ImplementationMay participate in the development and optimization of data management SOPs, processes, and initiatives.
Here's What You'll Bring to the Table:
Bachelor's Degree in an analytical or health-related field8+ years of clinical data management experience in industry, with experience across indications and relational databases and experience using multiple clinical data management systemsPhase 1-IV clinical development experienceMulti-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 recommendationsSuccessful experience managing vendor relationshipsExpert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processOutstanding verbal and written communication skills, in addition to excellent organizational skillsDemonstrated 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.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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras About ModernaSince 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 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 applyModerna 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 (EEO/AAP Employer) -