At ProClinical, we are currently seeking an individual to fill the role of QC Associate Contractor, based in Cranbury, NJ. The ideal candidate will review and compare clinical and regulatory submission documents, clinical study reports, protocols, versus source documents for accuracy, content, formatting and compliance to local guidance.
- Understand statistical data listings, tables and figures to ensure they are incorporated and interpreted appropriately into documents.
- Verify source data in clinical study reports and regulatory submission documents.
- Experience in reviewing statistically generated Tables, Listings and Figures, reviewed clinical study reports and submission documents.
- Assist in the resolution of comments from Quality Assurance.
Skills And Requirements
- BS or equivalent experience and 5+ years' industry experience in a QC role.
- GCP training, particularly in areas such as data reporting and clinical trial management.
- A minimum of 5 years of QC experience for a pharmaceutical company is preferred.
- Good understanding of GCP, study table, listings and figures, eCTD (Common Technical Document) and clinical operations procedures.
- Proficient in Microsoft Office.
- Excellent written, verbal, and interpersonal communication skills.
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) 2674056995 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.