Associate Director, External Data Management
Associate Director, External Data Management
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Job Description
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.
Heres What Youll 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.
Heres What Youll Need
Required Education Experience Certifications:
Bachelors 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. Thats why our US benefits and global well-being resources are designed to support youat 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 to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
- Savings and investment opportunities
- 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.
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.
Our Working Model
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.
Moderna is a smoke-free alcohol-free and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Accommodations
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 .
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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Required Experience:
Director
Employment Type
Full-Time
