ProClincal is recruiting for an exciting new contracted position as QC Associate Contractor based in Cranbury, NJ. The right candidate will review and compare clinical and regulatory submission documents, clinical study reports, and protocols to source documents for accuracy, content, formatting and compliance to local guidance.
- Understanding statistical data-listings, tables and figures to ensure they are incorporated and interpreted appropriately into the written document.
- Verifying source data to written document in clinical study reports and regulatory submission documents.
- Assisting in the resolution of comments from Quality Assurance.
- Cross-functional interactions include medical writing, QA, regulatory, Pharmacovigilance, statistics and clinical teams.
Skills And Requirements
- BS Degree, or equivalent experience, plus a minimum of 5 year’s industry experience in a QC role.
- The ideal applicant would have GCP training, particularly in areas such as data reporting and clinical trial management, as well as experience in written communication.
- Minimum of 5 years of QC experience for a pharmaceutical company preferred.
- Comprehensive understanding of GCP, Study Table, Listings and Figures, eCTD (Common Technical Document) and clinical operations procedures.
- Proficiency in Microsoft Office.
- Experience in reviewing statistically generated Tables, Listings and Figures, reviewed clinical study reports and submission documents preferred.
- Communicate well with cross functional areas such as medical writing, regulatory, data management and statistics.
- Support the clinical operations functions in responding to Quality Control Audits and Regulatory Inspections.
- Ability to communicate with other functional groups on the documents needed, such as source documents, to perform a 100% QC.
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 call Matthew Goldberg at (+1) 267 405 6995 or upload your resume 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.