Senior Manager, Clinical Systems

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

The Senior Manager, Clinical Systems, Clinical Operational Excellence will assist with the day-to-day operations of important clinical systems (i.e. Clinical Trial Management System, Trial Master File, etc.) that support clinical trial execution and management. The individual will be a part of a team tasked with initiating and managing transformative initiatives. These initiatives will require collaboration among many different stakeholders and contributors including Development Operations, Information Technology, key stakeholders, and external vendors.

The Opportunity to Make a Difference

• Participate in transformative initiatives that create effective and efficient processes that meet high compliance standards, collaborating across Development Operations
• Collaborate with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver commitments to the organization and to patients
• Support the maintenance of clinical systems (CTMS, TMF, etc.) in support of related processes
• Ensure system administrative and study-related set-up activities are defined, appropriate, and carried out in a timely manner
• Oversee system user access management
• Collaborate with the system and technology team to support data aggregation and reporting
• Ensure the system and associated activities are managed within appropriate timelines
• Actively support the strategic vision for clinical systems to maximize end user focus and engagement
• Partner with key internal and external stakeholders to remediate risks and manage emerging issues
• Use proactive approaches to process improvements and enhancements of clinical system capabilities and standards
• Participate in system related change control activities
• Keep current on changes in industry and regulatory standards for GCP requirements and advise on business impact for clinical systems
• Provide systems support for audits and inspections
• Promote a culture of continuous improvement; acts as a change champion, and effectively lead change
• May support additional ad-hoc activities as agreed upon with Clinical Operations Excellence department head and Associate Director, Clinical Systems
• Works on issues where analysis of situations or data requires an in-depth knowledge of Clinical systems
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
• The incumbent would be regularly interacting with the internal department team, cross functional team, as well as external vendors

More about You

• Expert knowledge of Clinical Systems – CTMS, TMF, etc.
• Experience with liaising with IT and QA for change controls/upgrades
• Able to effectively communicate on clinical operations topics both internally and externally
• Able to maintain a high level of quality, accuracy, and attention to detail in a fast-paced environment with shifting priorities
• Must be proactive, self-motivated, excel at relationship building, and able to work independently with minimal supervision
• Must have strong work ethic, excellent organizational skills, strong or