Clinical Quality Control Reviewer

Responsibilities:

• Data Quality Review / Quality Control (DQR/QC): - Independently performs DQR/QC on clinical components of assigned documents (eg, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses, etc.).

• Formally documents findings of assigned documents. 

• Supports accuracy, internal consistency, uniformity and compliance with clinical and regulatory commitments and expectations. 

• Alerts supervisor and document authors immediately if significant problems are found during a review. 

• After completion or throughout the review, prepares written report of findings and record of the DQR/QC. 

• Participates in resolution of findings with the document authors, clinicians and other members of the medicine team if necessary.  

• Archives relevant documentation in the appropriate repository according to established departmental practices. 

• Manages the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses and corrective action planning with customers as necessary.

Reporting Tasks: -

• Provides ongoing analysis of data resulting from the quality review of regulatory submission documents. 

• Records assignments in relevant tasks logs. 

Experience:

• Minimum 3 years of clinical and data management experience in the pharmaceutical/healthcare industry. 

• This should also include a minimum of 3 years medical writing and DQR/QC experience of clinical documents. 

• An understanding of scientific principles, knowledge of medical terminology and familiarity with the AMA Manual is required. 

• The ability to edit to clear writing is required, as are strong verbal, written, and interpersonal communication skills, and the ability to pay rigorous attention to detail while working rapidly and accurately. Preparation of clinical regulatory documents is strongly preferred. 

• This experience can be obtained in a clinical setting, at a pharmaceutical company or CRO. 

• No Travel/No Overtime