Associate Director, Clinical Data Management, Infectious Disease

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 Moderna

Here’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 deliverables

• Responsible 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 Pharmacovigilance

• Responsible 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 review

• Lead 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 Implementation

• May 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 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-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 process

• 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 c