Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
This individual is an seasoned clinical data management leader and reports to the Head of Clinical Data Management. 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 provides, eCOA, IRT, etc.) across the clinical data management function. This individual provides expertise in clinical data management and leads across the Data Management function to effectively support all clinical trials across all Sarepta’s clinical development programs.The Opportunity to Make a Difference
Accountable for all Data Management timelines and quality of external data deliverables in collaboration with other functionsDevelop and manage the standards, data transfer specifications, and data flow for collection and and on-going review of external clinical trial dataDevelop strategies and transition plans to implement more process automation and real-time data flow from external vendor partnersCollaborate closely with IT colleagues on the development, implementation, and management of an integrated clinical trial data repository for the data management teamEnsure that a well-functioning governance structure is in place and followed for CRO and all external vendor partners. Measures vendor success through mutually agreed key performance indicators (KPIs) and service level agreements (SLAs)Provide technical and process leadership for external data to cross-functional teamsForecast and manage Data Management resources and budget to meet current and future business needsSelect and manage external data vendors to meet regulatory requirements, quality standards, timelines and budget constraintsOversee directly or through team members 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 Oversee directly or through team members database lock activities to ensure high quality data with proper documentation and inspection readinessCollaborates with Clinical Operations Excellence team members in leading, developing, and implementing cross-functional platform solutions to support all aspects of data collection and reportingEnsure close collaboration of Data Management with other functions in various activities to achieve program and trial level goalsDevise or oversee development of external data vendor KPIs and metrics to inform cross-functional teams and support vendor oversightResponsible for coaching, mentoring, and performance management of direct reportsMore about You
Bachelor's degree or higher, preferably in a data science or health related discipline10+ years of clinical data management experience in pharma/biotech industryPrevious experience and leadership in managing external data providers for Data Management (i.e., central labs, specialty vendors, eCOA, IRT, etc.)Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industryStrong technical skills in database design, data transfer requirements, and data flowPrevious experiences in leading machine learning, AI, and robotic process automation (RPA) projects in clinical development is preferredA strong cross-functional leader who understands and can speak to the needs of organizational stakeholdersExperience in managing an outsourced data management modelFamiliarity with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data managementFamiliarity with CDISC model and associated CDASH and SDTM standardsExperience in leading Data Management for a BLA or NDAExcellent written and oral communication skillsExcellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment7 years of experience in leading/managing a Data Management team, including hiring, managing, mentoring and/or developing direct reportsWhat Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.