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