Director, External Data

Role Summary

This individual is an experienced clinical data management leader and reports to the Head of the External Data team within the Clinical Data Management function. This role is accountable to oversee and lead all activities associated with the collection, transfer, and quality of clinical trial data collected from external sources (i.e., central labs, specialty data providers, eCOA, IRT, etc.) across the clinical data management function. This individual provides both subject matter and technical expertise in clinical data management and supports multiple therapeutic area teams as an external data specialist.

Responsibilities

• Accountable to support all Data Management timelines and quality of external data deliverables in collaboration with the study Data Management leads other development functions
• Measures vendor success through mutually agreed key performance indicators (KPIs) and service level agreements (SLAs)
• Manage the standards, data transfer specifications, and data flow for collection and on-going review of external clinical trial data
• Develop process automation tools and processes to enable real-time data flow from external vendor partners
• Provide subject matter expertise and external data leadership to the clinical trial data repository development team
• Provide technical and process leadership for external data to cross-functional teams
• Collaborate with the Early Research and Gene Therapy Center of Excellence teams to streamline data flow and data review requirements
• Manage external data vendors to meet regulatory requirements, quality standards, timelines and budget constraints. May participate in external data vendor selection activities
• Partner with study Lead DMs and Clinical Trial Teams (CTTs) in the on-going external data updates, data reconciliations between EDC and external sources, and on-going data cleaning to enable high-quality data snapshots and soft locks to support various trial and/or program activities
• Provide external data leadership and support for key database lock activities to ensure high quality data with proper documentation and inspection readiness
• Collaborate with Clinical Operations Excellence team members in implementing cross-functional platform solutions to support all aspects of data collection and reporting
• Ensure close collaboration of Data Management with other functions in various activities to achieve program and trial level goals
• Develop and oversee new or revised external data vendor KPIs and metrics to inform cross-functional teams and support vendor oversight

Qualifications

• 8+ years of clinical data management experience in pharma/biotech industry, with previous external data oversight experience expected
• Previous experience and leadership in managing external data providers for Data Management (i.e., central labs, specialty vendors, IRT, etc.)
• Previous experience and leadership with Electronic Patient Reported Outcomes (ePRO) and Electronic Clinical Outcomes Assessments (eCOA) is preferred
• Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
• Experience in managing an outsourced data management model
• Familiarity with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
• Familiarity with CDISC model and associated CDASH and SDTM standards
• Experience in leading Data Management for a BLA or NDA
• Travel as needed to support study activities and vendor oversight

Skills

• Can translate highly technical concepts and requirements to cross-functional stakeholders
• Strong interpersonal and collaboration skills with the ability to work independently in a dynamic team environment
• Excellent written and oral communication skills
• Familiarity with GCP, ICH, and FDA regulatory requirements as applicable for clinical data management
• Familiarity with CDISC CDASH and SDTM standards
• Experience in leading machine learning, AI, and robotic process automation (RPA) projects in clinical development is helpful

Education

• Bachelor's degree or higher, preferably in a data science or health related discipline

Additional Requirements

• Hybrid work arrangement; on-site at Sarepta facilities in the United States and/or attendance at Company-sponsored in-person events from time to time
• Candidates must be authorized to work in the United States