Clinical Data Coordinator
Proclinical is currently recruiting for a Clinical Data Coordinator with a biopharmaceutical company located in Waukegan, IL.
- Responsible for creating templates and labels for Clinical Supplies used in Clinical Studies.
- Attention to detail is of paramount importance.
- Compares different source documents and ensures that the information is consistent and accurate with the clinical label.
- Requires use of a design program to create the .pdf proof of the label design.
- Responsible for implementing and maintaining the effectiveness of the quality system; reviews, proofreads and approves Clinical Labeling.
- Reviews labeling for consistency with similar or related product labels.
- Communicates and coordinates labeling and documentation approvals with worldwide affiliates.
- Interaction and professional communication with business partners around the world is required. All communication is in English.
- Must be able to rearrange priorities on short notice to react to business needs.
- Labeling and documentation for clinical supplies must be completed accurately and within the designated timelines.
Skills and Requirements:
- High School diploma required, BA/BS degree preferred in Science, English, Business or related field to ensure accuracy of highly technical information used by Clinical Operations and regulated by the FDA.
- Knowledge of regulations and standards a plus.
- Must have the ability to problem solve, manage multiple projects simultaneously, influence internal and external groups and provide leadership.
- Strong organizational and human relations skills to deal with various levels of individuals and functional areas within the division.
- Previous experience working within a change control system is helpful.
If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.