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 Manager, Clinical Operations Excellence will report into the Senior Manager, Clinical Operations Excellence and will provide subject matter expertise to facilitate optimal clinical development operations, GCP compliance, and trial oversight. Primarily, this role will support Development Operations with SOP reconciliation, development, and management to ensure accuracy and compliance; CTMS support and support development and implementation of process improvement initiatives to ensure efficiency and consistency within the Development Operations and compliance with GCP.The Opportunity to Make a Difference
Participate in transformative initiatives that create effective and efficient processes that meet high compliance standards, collaborating across Development OperationsGap analysis and reconciliation of Development Operations-owned SOPs; and management of SOPs per Sarepta guidelinesDrive Clinical Operations Excellence by managing oversight activities for cross-program monitoring oversight programProvide oversight and coordination of applicable governance forums; inclusive of KPI collection and dissemination to appropriate partiesSupport compliance activities including SOP activity and training compliance; support teams with risk management/mitigation in accordance with the requirements of ICHE6(R2)Support process-build of clinical development process and business area SOPs as fit for purpose and in compliance with regulatory requirements; confirm SOPs are an accurate representation of the way work is executedProvide input and support for training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and on- going adherence to standards and regulationsAssist with the creation and delivery of tools, templates, training, and guidance for best practice and reporting and minimizing risk while ensuring quality is integrated into our processesDrives overall CTMS implementation within Development Operations and be a change agent for the system within Sarepta to ensure adoption of new capabilities and business processPartner with appropriate functional stakeholders, technology vendors, and CRO partners to avoid and resolve risks within the CTMSSupport an ongoing community of practice and functional superusers for CTMSLiaise with internal R&D Business Operations and R&D Quality and Compliance to execute best practice relationship infrastructures, and efficient, high quality & compliant business processesMay support additional ad-hoc activities as agreed with Senior Manager, Clinical Operations ExcellenceMore about You
Experienced in supporting clinical trial GCP compliance/quality management activitiesExperience in CTMS systems and supporting implementation and maintenance within the systemExcellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timelyAbility to work independently and manage deadlinesExcellent interpersonal and communication skills (both written and oral) including ability to develop strong relationships with both internal and external customers in a matrix environment and to timely escalation conflicts for resolutionProblem-solving, process improvement, analytical, and collaborative skillsSelf-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful changeExperience with corrective/preventive actions and effectiveness checksKnowledge of Clinical Systems – CTMS, TMF, etc.Able to implement directives, meet deliverable timelines, exercise managerial discretion, advanced analytical/forward thinking and prioritization skills, and escalates when necessaryAble to maintain a high level of quality, accuracy, and attention to detail in a fast-paced environment with shifting prioritiesMust have strong work ethic, excellent organizational skills, strong oral and written communication skills, have a ‘can do’ approach, strong problem-solving skills, and be a team playerExtensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, ICH-GCP guidelines, International Council for Harmonization E6(R2) guidelines and other applicable major Health Authority regulationsAbility to manage and navigate multiple electronic Clinical systems and advanced proficiency in Word, Excel, and PowerPointPosition may require some travelBS/BA degree or equivalent required with 5+ years of related experience5+ years of experience gained with a CRO, biotech, or pharmaceutical company#LI-TD1
What 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.