Director, Clinical Data Management, Infectious Disease, COVID

The Role:

Moderna is seeking a Director, Clinical Data Management, Infectious Disease, COVID, to define and lead the clinical data management strategy for the Infectious Disease Therapeutic Area for the COVID program. This role will report to the Senior Director, Clinical Data Management at Moderna.

Here’s What You’ll Do:

• Define, implement and monitor the data management efforts and initiatives for the Moderna Infectious Disease Therapeutic Area across all trials and studies for the COVID Program.

• Guide and mentor, a team of clinical data management leaders and represent the Moderna data management function for the COVID program; performs as a data management SME for all COVID data related topics, process and data handling

• Ensures aligned expectations between external data vendors and the Moderna cross-functional stakeholders for all data related deliverables; monitors the quality of all data deliverables, anticipates and mitigate the risks and measures the performance through metrics and KPIs

• Responsible for data vendor oversight activities including consistency, quality and timeliness of all deliverables across COVID Program in compliance with GCP, SOP and regulatory requirements

• Ensures that subcontracted activities are delivered in line with the project expectations (timelines, quality and budget). Follows budget and potential change orders for external data vendors

• 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 defining and implementing data management standards and processes to be utilized within the COVID Program

• Responsible for leading/overseeing the design, creation, testing and implementation of data capture tools and integrations for data capture, data processing, 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 overseeing and contributing to 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 process for the COVID; 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 trend analysis

• Participate in the implementation of data quality systems and procedures and identify any needs for improvement. Perform new technologies intelligence and adapt to them as appropriate. Participate in the continuous improvement of the Data Management system.

• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. Represents COVID Data Management in inspections, audits and inspection related activities

• Lead/contribute to/participate in Moderna Data Management Initiatives and Innovation Implementation.

• Participate in the development and optimization of data management SOPs, processes and initiatives.  Support cross-functional process definition, innovation and optimization

Here’s What You’ll Bring to the Table:

• Bachelor’s Degree in an analytical or health-related field

• 10+ 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 processes

• 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

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) 

-