Document Quality Manager/Auditor

SUMMARY

- Responsibilities cover the following specific areas of Document Quality Review clinical data checking/internal consistency checking against source documentation, clinical editing, and special assignments/writing projects and perform internal review/assessments.
- Candidates must be familiar with audits and especially with clinical documents for FDA submissions.
- They will need to execute quality plans and do document reviews, assess trends and identify root cause and maintain metrics. Need broad experience
- 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,
- Clinical Study Reports (CSRs), Statistical Analysis Plans (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 identified in the clinical quality plan.

2. Special Assignments/Projects:

- Independently produces guidance documents, QC Checklist, training, best practices, in line with business requirements may prepare special reports as needed and coordinate contributions to data integrity plans.
- 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)

SKILLS:

MAIN REQUIREMENTS FOR THIS ROLE:

- Quality of submission experience
- Strong GCP and Auditing a must
- Quality assessment
- Manager looking for Audit of clinical - candidates have to know how to execute an Audit plan.
- Training background required
- Former regulatory submission process very helpful
- Background in statistics, clinical operations, clinical research, data management, programming
- The manager is looking for someone who has well rounded experience in Clinical Research and familiar with Good Clinical Practices (GCP).
- Who has auditing background of documents for regulatory NDA submissions.
- Someone who can execute quality plans and assess root cause across clinical development functions
- PlProven 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
- Experience reviewing clinical protocols and study reports and NDA clinical documents
- Candidates MUST have experience executing Audit Plans and identifying root cause.
- Need to have a lot of Clinical Research experience and lots of GCP experience.