Senior Clinical Document Specialist

Location
South San Francisco, California
Posted
Aug 03, 2018
Required Education
Bachelors Degree
Position Type
Full time

Principia Biopharma is a clinical stage biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and inflammation. As such, we are comprised of a team of exceptionally talented scientists and business leaders. We are seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and is a driven, strategic and collaborative leader. The ideal candidate will contribute in a culture of high performance, empowerment, learning, diversity and has a desire to be part of the department’s leadership and the willingness to grow in their responsibilities.

The Role:

The Clinical Document Specialist will be responsible for Trial Master File (TMF) quality per ICH GCP guidelines. He or she will prepare, process, and track documents received (paper and electronic), per project requirements, in a timely manner. He or she will ensure that documents are scanned, imported, coded, and indexed into the Trial Master File (paper, electronic, or both) and reviewed for quality on an ongoing basis. He or she will implement internal quality control (QC) checks of CRO and vendor TMFs as well as Principia in‑house TMFs and will ensure the conduct of independent periodic quality assurance (QA) audits of CRO and vendor TMFs as well as internal TMFs. The ultimate responsibility will be to ensure that all TMFs are submission and inspection ready on an ongoing basis.

Essential Responsibilities

  • Global responsibility for TMF quality for all Principia-sponsored studies (in-house and contracted)
  • Establish and execute written procedures for timely preparing, processing, and tracking of paper and electronic TMF documents

 

  • Author and Owner of TMF Procedures 
  • Author/contribute to study-level Trial Master File Plans.
  • Establish and execute written procedures for maintaining working files as well as for scanning, importing, indexing and  tracking of documents into the electronic TMF
  • Establish procedure for reviewing TMF documents for quality on an ongoing basis
  • Establish and execute written procedures for timely archiving of paper TMF documents and for maintaining an ongoing inventory list of all received documents
  • Establish and maintain written procedures that are current with industry changes on TMF management, quality, and archiving
  • Participate and become an expert in the DIA TMF Reference Model and stay current on updates and revisions
  • Assist in training project team members on essential documents and regulatory requirements
  • Take a proactive role in learning about and educating the project team on general TMF-related topics
  • Ongoing TMF Ownership and Oversight
  • Assist in development of project timelines
  • Liaise with internal and vendor cross-functional team members to ensure completeness and quality of documents
  • Manage TMF vendors and, as applicable, other vendors to ensure compliance and oversight
  • Provide electronic document publishing support (ie, scanning, OCR, rendering, bookmarking and linking, document validation, and compiling)
  • Perform document control functions and maintenance
  • Monitor and update management on project progress, ensure strict adherence to deadlines and budgets, and ultimately produce high quality deliverables

  • Ensure Audit-Readiness of TMFs
  • Overall, ensure submission and inspection readiness of the TMFs
  • Perform Internal QC checks and oversee independent QA audits of all TMFs (in-house and contracted)
  • Support the clinical operations teams in the preparation, conduct, and follow up of internal and external audits and inspections
  • Non-TMF Document Responsibilities
  • SOP administration, tracking of SOP training, administration of clinical department training records
  • Administer the clinical department’s centralized electronic working files on

Perform document control functions and maintenance  

 

Qualifications

  • Proficiency in Microsoft Office (Word, Excel, Outlook), electronic TMF, and electronic clinical technologies
  • Working knowledge of Microsoft SharePoint
  • Multi-task in a fast paced environment
  • Work without close supervision both independently and as part of a team
  • Proactively foresee and solve problems and commit to a high level of service
  • Build strong cooperative relationships with coworkers
  • Work well with people from a variety of different backgrounds and cultures
  • Write complex documentation without direct supervision
  • Possess a high degree of attention to detail
  • Propose solutions and schedule all problem solving activities under indirect supervision in clear project plan with defined goals, decisions, and endpoints
  • Develop new procedures where needed Proficiency in Adobe Acrobat, ISI Tools, and web-based document indexing and electronic document retrieval systems.
  • Proficiency in document publishing, including scanning, extracting, uploading, OCR, rendering, bookmarking and linking, document validation, and compiling
  • Previous employment at a pharmaceutical or biotech company or CRO Experience in collecting, scanning, coding, and indexing TMF documentation
  • Knowledge of clinical development phases and processes including GCP and ICH regulations
  • Previous experience overseeing TMF audits and inspections (internal and by external parties)
  • Experience in overseeing and training employees on TMF procedures and regulatory requirements  

Education

  • BA or BS degree with a minimum of 5 years relevant experience in a life science industry; or equivalent combination of education and experience.
  • 5 – 8 years relevant GCP experience (working knowledge of GCP documents) and TMF management experience

Language skills:

  • Superior written and spoken communication skills in English
  • Ability to clearly communicate problems and observations to management from other departments
  • Ability to present complex problems and observations to management

Reasoning ability:

  • Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions
  • Work on complex problems where the analysis of situations or data requires in-depth evaluation
  • May determine methods and procedures on new assignments and may provide guidance to other lower level personnel

Principia Biopharma, Inc. is an equal opportunity employer.