Senior Manager, Records Management
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
The Senior Manager of Records Management oversees and assures appropriate planning and coordinates activities of the Record Management group. This position supervises Record Management staff and ensures compliance with Ultragenyx processes and SOP’s. The Senior Manager of Records Management has a high degree of expertise and practical experience in clinical trial management and record management. The person will act as a TMF subject matter expert across all business partners in document content, technologies, and processes.
Responsibilities, including but not limited to:
- Ensure standardization, quality, and timely clinical trial documentation across the clinical program
- Promote the consistent use and application of technology and standards. The ultimate objective is to have a complete and accurate Trial Master File
- Provide expertise and guidance related to relevant and current TMF regulations and guidelines, as well as expertise in documentation management according to the DIA Reference Model
- Participate in the preparation of audits/inspections and presents information relative to functional area
- Develop Standard Operating Procedures (SOPs) and guidelines related to the TMF management
- Supervises Record Management group staff
- Ensure staff development and performance feedback are provided through activities such as mentorship and career development
- Communicate team and individual goals and expectations to ensure direct reports understand their responsibilities
- Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotions
- Promote a positive and professional work environment
- Ensure proper training and resourcing of staff
- Partner with core and extended study team members to resolve document discrepancies
- Act as a change agent to ensure minimal organizational disruption during new system/process implementation
- Bachelor degree or equivalent required (scientific or technical discipline preferred)
- 8+ years of clinical operation experience
- PC literacy required; MSOffice skills (SharePoint, Outlook, Word, Excel, PowerPoint)
- Experience supporting GCP inspections (e.g., FDA, PMDA, EMA, MHRA)
- Prior eTMF experience (e.g., Documentum, Veeva Vault eTMF, Wingspan)
- Detailed understanding of clinical trial operations and regulations (Good Clinical Practice, 21 CFR Part 11)
- Experience with or understanding of clinical trial related documentation
- Ability to lead cross-functional teams and change initiatives through implementation with little or no oversight
- 2+ years prior experience in managing employees
- Previous employment in Records Management
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: email@example.com.