Senior Clinical Document Specialist

Ultragenyx

Novato, CA (REMOTE)

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease. 

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.

Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding.

Position summary:

ultrafocused – Work together to fearlessly uncover new possibilities

This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Ultragenyx Standard Operating Procedures (SOPs) as appropriate.  The Senior Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs.  This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection ready according to Ultragenyx SOPs and applicable regulations.

Responsibilities including, but not limited to:

  • Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
  • Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders
  • Review and classify documents collected from internal and external sources
  • Reconcile essential documents in both hard/soft copies to avoid duplication
  • Support study teams with the TMF quality review process
  • Perform QC and maintenance of  eTMF/TMF for assigned studies
  • Perform data entry and reconciliation in various clinical systems and tracking tools
  • Provide input on revision of TMF related Work Instructions and SOPs
  • Provide direct TMF support to clinical trial activities conducted by Ultragenyx
  • Follow up on quality findings
  • May provide training and mentoring activities for new and current staff
  • Manage paper document filing process including Novato Record Room oversight. 
  • This position will require being present at the Novato campus on a weekly basis as needed to cover Record Room access requests

Requirements:

  • Bachelor's or Associate's degree with a minimum of 4 years of professional clinical document management experience
  • Demonstrated knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
  • Experience with electronic trial master file system(s) including uploading, reviewing, quality checks (QC), approval of study required documents.
  • Working knowledge of DIA reference model
  • Familiarity with international clinical trials, clinical trial documents and document QC process highly  desirable
  • Good communication and interpersonal skills
  • Good time management skills, excellent attention to detail, and ability to multi-task in a high volume environment
  • Team oriented and flexible; maintaining integrity and high ethical standards
Apply here