CS3 Associate Contractor
3551 Lawrenceville Road Trenton, NJ 08648 US
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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.