Manager, Clinical Operations Excellence

Job Description

Job Description

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.

Were 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 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 on- going 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
• May support additional ad-hoc activities as agreed with Senior Manager, Clinical Operations Excellence

More About You

• 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

What Now?

Were always looking for solution-oriented, critical thinkers.

So, if youre 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.

This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and / or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $112,000 - $140,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.

The salary offer is commensurate with Sareptas compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity / Affirmative Action employer and participates in e-Verify.

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