Associate Director, External Data Management

The Role: 
The Director or Associate Director, External Data Management will define and lead the strategy, oversight, and execution of data acquisition, integration, and quality assurance for all non-EDC clinical data sources.  This includes but is not limited to central laboratory data, biomarker data, pharmacokinetic/pharmacodynamic (PK/PD) data, imaging, wearable devices, and other external vendor-generated data.  This role will be critical in ensuring high-quality data flow into the Moderna environment to support decision-making, regulatory submissions, and future analytical use.

Here's What You’ll Do: 

• Key responsibilities include: 

• Providing strategic leadership in the planning and management of all external (non-EDC) data streams for clinical trials across all phases.

• Depending on the operating model, serving as the primary point of contact for external data vendors, ensuring timely delivery, compliance with data specifications, and adherence to data quality standards.

• Overseeing and contributing to the development of all Data Management documentation for non-EDC data including Data Transfer Specifications, Data Validation Specifications, Data Handling Guidelines, etc.

• Ensuring compliance with regulatory requirements and industry standards (e.g., CDISC, ICH, GCP) in handling external data.

• Defining and implementing standards and processes for handling non-EDC data (e.g., clinical biomarker data) to be used across the Moderna portfolio; ensuring adherence and consistency of standards across the portfolio. 

• Developing and implementing best practices and SOPs for external data management, including data cleaning, reconciliation, and audit readiness.

• Leading/participating in the identification, implementation and adoption of innovative data management and processing systems, processes procedures supporting non-EDC data.

• Collaborating cross-functionally (e.g., Clinical Operations, Biostatistics, Biometrics) to align data management approaches with broader program and study needs.

• Ensuring aligned expectations between external non-EDC data vendors and the Moderna cross-functional stakeholders for all non-EDC data cleaning related deliverables; monitoring the quality of all data deliverables, anticipating and mitigating the risks and measuring the performance through metrics and KPIs.

• Mentoring and managing a team of external data managers or cross-functional contributors.

Here’s What You’ll Need

• Required Education, Experience, Certifications:

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

• 8+ years of clinical data management experience.

• Strong understanding of clinical data flows, especially from external vendors (labs, imaging, wearables, eCOA, etc.).

• Experience with data integration tools, standards (CDISC SDTM), and data platforms (e.g., RAVE, Veeva, SAS, Spotfire, etc.).

• Expert knowledge of FDA and ICH regulations and industry standards applicable to data integrity and handling of non-EDC data.

• Team management experience in resourcing strategy and estimation.

• Outstanding verbal and written communication skills, in addition to excellent organizational skills.

• Excellent interpersonal skills, ability to develop important relationships with key stakeholders including cross-functional teams and global stakeholders 

• Successful experience managing vendor relationships.

• Excellent problem-solving skills, including ability to analyze complex issues and develop relevant and realistic solutions.

• Excellent conflict management and negotiation 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. 

• Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.

• This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access