Senior Manager, Clinical Systems

Sarepta Therapeutics • Cambridge, MA

269d • $132,000 - $165,000 • Hybrid

About The Position

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.

Requirements

• 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 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, and International Council for Harmonization E6(R3) guidelines
• Must have ability to manage and navigate multiple electronic Clinical systems and advanced proficiency in Word, Excel, and PowerPoint
• BS/BA degree or equivalent required with 7+ years of related experience
• Prior clinical research experience including relevant clinical systems

Responsibilities

• 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

Benefits

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree