Clinical QA Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
Malvern, Pennsylvania
Posting date: 09 May 2019
QA.MJ.23225_1557420600

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Clinical QA Specialist position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its Pennsylvania-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

Job Responsibilities:

  • Performs accurate and precise editing or proof- reading to include spelling, grammar, punctuation and verification of data.
  • Assesses validity of clinical statements described in documents provided to governmental Health Authorities and identify discrepancies.
  • Provides independent clinical review of clinical summary documents, study reports, Investigator's Brochures, Clinical Protocols, Briefing Books, etc, prior to submission to Health Authorities.
  • Ensures quality and timeliness of reviewing and editing of clinical documents and submissions.
  • Verifies content to ensure accuracy (100% review) of all factual statements within document text compared to post-text sources cited (when appropriate).
  • Verifies numeric accuracy (100% review) of all data cited throughout text compared to in-text or post-text tables.
  • Verifies citation notation on all internal and external citations noted within summary document.
  • Ensure compliance of document format per the template and Style Guide.
  • Develops and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors.
  • Mentors and/or trains new or junior QC specialists to achieve department set goals for excellence in quality review.
  • Provides cross-divisional support through quality review of T&D documents and other non-traditional clinical documents.
  • Leads resolution of discrepant findings with Submission Team or author, including documenting actions, verifying implementation of findings and archiving results (if appropriate).
  • Works cross functionally to continuously improve processes.

Skills and Requirements:

  • BA, BS, or BSN is required; advanced degree is preferred.
  • Demonstrable experience in a similar or relevant role.
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at + 267-477-4800 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-MJ1

#Compliance/Quality

close