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Director of Clinical Operations Excellence
1 month ago
Sarepta Therapeutics is a leading biotechnology company dedicated to delivering life-changing therapies for patients with rare genetic disorders. We are committed to pushing the boundaries of innovation and making a meaningful impact on people's lives.
SalaryThe estimated salary range for this position is $112,000 - $140,000 per year. This compensation package reflects Sarepta's commitment to attracting and retaining top talent while considering factors such as education, experience, external market conditions, and internal equity.
About the RoleWe are seeking an experienced Clinical Operations Excellence Manager to join our team. In this role, you will play a critical part in shaping the future of clinical development operations at Sarepta. You will provide subject matter expertise to facilitate optimal clinical development operations, GCP compliance, and trial oversight.
This position requires strong organizational skills, attention to detail, and excellent communication abilities. You will be responsible for supporting Development Operations with SOP reconciliation, development, and management to ensure accuracy and compliance; CTMS support and the development and implementation of process improvement initiatives to ensure efficiency and consistency within the Development Operations and compliance with GCP.
Key Responsibilities- Participate in transformative initiatives that create effective and efficient processes that meet high compliance standards, collaborating across Development Operations.
- Gap analysis and reconciliation of Development Operations-owned SOPs; and management of SOPs per Sarepta guidelines.
- Drive Clinical Operations Excellence by managing oversight activities for cross-program monitoring oversight program.
- Provide oversight and coordination of applicable governance forums; inclusive of KPI collection and dissemination to appropriate parties.
- Support 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 executed.
- Provide input and support for training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and ongoing adherence to standards and regulations.
- Assist 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 processes.
- Drives overall CTMS implementation within Development Operations and be a change agent for the system within Sarepta to ensure adoption of new capabilities and business process.
- Partner with appropriate functional stakeholders, technology vendors, and CRO partners to avoid and resolve risks within the CTMS.
- Support an ongoing community of practice and functional superusers for CTMS.
- Liaise with internal RD Business Operations and RD Quality and Compliance to execute best practice relationship infrastructures, and efficient, high-quality compliant business processes.
- Experienced in supporting clinical trial GCP compliance/quality management activities.
- Experience in CTMS systems and supporting implementation and maintenance within the system.
- Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely.
- Ability to work independently and manage deadlines.
- Excellent 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 resolution.
- Problem-solving, process improvement, analytical, and collaborative skills.
- Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change.
- Experience with corrective/preventive actions and effectiveness checks.
- Knowledge 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 necessary.
- Able to maintain a high level of quality, accuracy, and attention to detail in a fast-paced environment with shifting priorities.
- Must 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 player.
- Extensive 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 regulations.
- Ability to manage and navigate multiple electronic Clinical systems and advanced proficiency in Word, Excel, and PowerPoint.
- Position may require some travel.
- BS/BA degree or equivalent required with 5+ years of related experience.
- 5+ years of experience gained with a CRO, biotech, or pharmaceutical company.
Sarepta offers a comprehensive benefits package designed to support the well-being of its employees. This includes physical and emotional wellness programs, financial wellness resources, and caregiver support.
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