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CS3 Associate Contractor

Trenton, NJ 08648

Posted: 11/29/2022 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 516055 Is job remote?: No Country: United States

Job Description

Assoc. BA/BS Degree, BA/BS Degree or LPN

4 or more years of experience in clinical research, with minimum of 2 years of that experience at a pharmaceutical company or CRO, including participation in data management and pharmaceutical safety reporting.
  • Experience working in clinical operations or safety surveillance role, demonstrating knowledge of project, protocol, site, data management, clinical/medical review, and signal detection and assessment.
  • Knowledge and understanding of the conduct and management of international clinical trials, particularly data collection processes from both clinical and data management perspectives.
  • Established experience working in a team environment within a matrix organization. Works well across organizational, functional, and geographic boundaries to achieve company goals.
  • Excellent oral, written, and interpersonal communication skills.
  • Demonstrated attention to detail and strong organizational skills.
  • Well-developed project management and leadership skills, including prioritization methods.
  • Knowledge and understanding of safety surveillance, risk management, and signal assessment capabilities and appreciation of overall R&D organizations (e.g., how they operate, key business drivers, etc.)
  • Strong knowledge of safety reporting, medical conditions/diseases, ICH/GCP Guidelines, and REMS/RMP.
  • Appreciation of medical concepts and safety reporting and visualizing safety messaging in clinical trial setting
  • Working knowledge of computer applications including Microsoft Office Suite, Oracle based systems, Trial Management systems, electronic data capture (RAVE), MedDRA library, J-Review, Spotfire
  • Working knowledge of programming languages including Python/R and Visual Basic and others preferred
  • BioPharma Behaviors Required - Speed, Innovation, Passion, Accountability
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