Janssen R&D, L.L.C. is recruiting for a Principal Clinical Operations Specialist - Oncology Translational Research to be located in Springhouse, PA or Raritan, NJ.
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The Principal Clinical Operations Specialist – Oncology Translational Research is responsible for facilitating the development and institution of biomarker plans for the evaluation of biological therapeutics in clinical development. As a biomarker clinical team and study team representative, the primary responsibility of the Principal Clinical Operations Specialist will be to implement program specific biomarker strategies in clinical trials while contributing biomarker related information to the preparation of clinical documents such as clinical protocols, clinical study reports and early development plans. They will also contribute to program and study specific biomarker plans for clinical stage gate review presentations and for other approval meetings. They will work closely with the biomarker lead on the CDT to identify and propose relevant biomarker assays (internal or external) to achieve the biomarker objectives of the program. They will closely work with representatives from other functional areas, such as Global Clinical Operations (GCO), clinical teams, medical writers, biostatistics and data management. Further, as operational representative for the clinical trials, the Principal Clinical Operations Specialist will present biomarker plans at investigator meetings and provide training to trial managers and site monitors. They will oversee and contribute information regarding biomarker sample collection and other procedures in synopsis, lab manual, vendor scope of work documents, laminated training materials and in informed consent forms for the sites. They will evaluate and implement new assays and relevant technologies as needed while maintaining an interface with commercial laboratories for assay development and assay transfer for implementation in clinical trials. The Oncology Translational Research Principal Clinical Operations Specialist is also responsible for supporting the Human Resources Planning (HRP) programs including management and staff development and training to meet current and future needs.
Responsible for, but not limited to: