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 Associate in our Parsippany, NJ - Headquarters.
The Clinical Trial Associate is to provide support for the planning, execution, and financial aspects of Phase I – IV clinical studies, including contracts and budgets, and other tasks completed to ensure the objectives of the studies are met. This position is responsible for assisting the oversight of a variety of consultants and CROs including site management, trial monitoring and accuracy of documentation for Clinical central files. The incumbent may work closely with internal Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and Executive staff, as well as external consultants, clinical research organizations (CROs), vendors, and clinical site personnel.
Responsible for the development and maintenance of the overall budget for the clinical department, including all phase I-IV studies.
Serve as liaison between Clinical Operations and Pacira’s Legal and Accounting departments in coordinating the set-up, review, and approval of clinical trial agreements, consulting agreements, master service agreements, and work orders, tracking and reporting the expenses against the budget.
Assist as needed with the general work of keeping up with clinical functions as they intersect with other functional areas.
Responsible for oversight of vendors/consultants, which includes communicating timelines, negotiating contracts, preparing purchase requisitions, and coordinating related activities.
Assist in the planning and set upas needed
Assist in development, maintenance, training and record keeping Clinical SOPs and guidelines in accordance with GCP, ICH, and FDA Guidelines.
Actively participate in design, development, and review of study protocols, reports, and case report forms to ensure compliance with GCP, ICH, and FDA guidelines.
Provide management support for activities with outside vendors and business partners, as required.
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Work with the finance group to develop tools and align on process, trackers, and timelines relating to activities that interface with company financials.
Bachelor’s degree or equivalent from an accredited college or university is required; Life Sciences degree preferred.
3+ years’ of health sciences experience is required (pharmaceutical industry or related experience is preferred; work in the areas of contracts, budgets, clinical operations, and/or project management a plus).
Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with medical terminology is necessary.
Ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment.
Proficiency using Microsoft Word, Excel and PowerPoint; Microsoft Project is a big plus.
Understanding of finance principles and applies to managing project budgets.
Excellent oral and written English communication skills.
Ability to present financial and technical information in a concise and clear manner.
Experience in various electronic data capture systems involving site enrollment and tracking is a plus.
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.