Document Quality Manager

SUMMARY:
The Document Quality manager responsibilities cover the following specific areas of Document Quality Review: clinical data checking/internal consistency checking against source documentation, clinical editing, special assignments/writing projects, and performing internal review/assessments.

JOB RESPONSIBILITIES:
1. Document Quality Review and QC Responsibilities:

- Independently performs data quality review/QC of assigned clinical, regulatory documents according to relevant SOPs, Policies and business practice to ensure internal consistency, as well as consistency with source documents, style guides, and FDA and ICH guidelines (eg, protocols, CSRs, SAPs, ISS/ISE summary documents, IBs, etc.) for the Clinical Development organization.
- Formally documents findings including issue resolutions of the assigned documents.
- Alerts manager and document authors immediately if significant problems are found during the quality review.
- After completion of document quality review, prepares written report of findings in a table of observations.
- Participates in resolution of observation with the document authors and if necessary, functional manager.
- Keeps management and authors informed on progress of document quality reviews.
- Archives relevant documentation in the electronic document management system or other appropriate repository according to established departmental practices.
- Initiates and prepared guidelines and QC Checklists per functional area and maintains QC Portal SharePoint site and establish metrics.
- Participate in and perform internal functional quality reviews as per planned requirements.

2. Special Assignments/Projects:

- Independently produces guidance documents, QC Checklist, training, best practices, in line with company and business requirements. May prepare special reports as needed.
- With general supervision, contributes to authoring training materials and tools as assigned by the manager.
- Evaluates routine processes and procedures.
- Analyzes QC findings to identify root causes of errors and discrepancies.
- Makes recommendations on process improvements and lessons learned that could reduce recurring errors in documents.

3. Administrative Tasks:

- For documents where quality reviews are outsourced, may assume responsibility for quality oversight and review of document to ensure consistent approaches for outsourced components.
- Perform proof-reading and QC review of documents prepared by internal or contract medical writing staff (cross checking the internal consistency of text between sections, as well as verifications of relevant text against tables, figures, and data listings etc., which may be either contained within or reference external sources)
- Act as a resource for medical writers/clinicians regarding proper utilization of style guides, document systems and document templates.

SKILLS:

SKILLS/QUALIFICATIONS:

- 1 - 3 Years
- Proven track record with regard to the preparation, development, and review of clinical documents in document management systems, using standard procedures is required
- Experience reviewing clinical protocols and study reports and NDA clinical documents
- Clinical Quality Assurance experience is a requirement
- Good Clinical practices (GCP) experience is a requirement
- Auditing background of documents for regulatory NDA submissions.
- Someone who can execute quality plans and assess root cause