Senior Manager Clinical Systems
Senior Manager Clinical Systems
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
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 limbgirdle 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 worklife 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: Importance of the Role
The Senior Manager Clinical Systems Clinical Operational Excellence will assist with the daytoday operations of important clinical systems (i.e. Clinical Trial Management System Trial Master File etc. that support clinical trial 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 studyrelated setup 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 adhoc 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 indepth 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 fastpaced environment with shifting priorities
- Must be proactive selfmotivated 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 problemsolving 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
What Now
Were always looking for solutionoriented 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.
Required Experience:
Senior Manager
Employment Type
Full-Time
