At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. We currently have an opportunity for a Clinical Trial Manager in our Parsippany NJ Headquarters.
The Clinical Trial Manager will execute all aspects of assigned clinical trials. This will include participation in design of clinical development plans, clinical trial synopses and clinical trial protocols. The Clinical Trial Manager will participate in the formulation of the overall clinical strategy including contributing to the Clinical Study Concept and Clinical Study Planning documentation. The CTM will participate in the site selection, qualification and initiation as well as scheduling of monitoring activities. Additional responsibilities include presenting at Investigator Meetings, performing monitoring visits, and ensuring site compliance with study protocols, and maintaining ICH-GCP documentation for trial sites. The CT< will participate in the development and maintenance of our Clinical infrastructure including writing and reviewing SOP’s and Work Instructions.
Bachelor degree in Life Sciences from an accredited College or University.
Demonstrated knowledge of FDA regulations and Good Clinical Practice (GCP) Guidelines as they relate to protection of human subjects.
Demonstrated knowledge of Electronic Data Capture systems, Monitoring Visits.
Successful completion of an accredited Clinical Trial Certification course.
2 years’ experience working within a Quality Assurance and Regulatory departments. .
Proficient in MSOffice including, Outlook, Word, Excel, Access, PowerPoint and MSProject.
Experience using and training others on various EDC systems.
Minimum 2 years of independently managing clinical studies.
Minimum of Six (6) years clinical research experience in the U.S. biotech/pharmaceutical industry.
Ability to travel up to 25% of the time including some weekends.
We encourage candidates who meet these requirements to submit a cover letter and resume/CV. Pacira Pharmaceuticals offers an excellent compensation and benefits package that includes Medical/Dental/Vision plans, life insurance, 401(K), short and long term disability and paid time off.
Pacira Pharmaceuticals, Inc. Is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients.