- J&J Family of Companies (Titusville, NJ)
- …Design Mindset, Drug Discovery Development, Entrepreneurship, Good Clinical Practice ( GCP ), Lateral Leadership, Medicines and Device Development and Regulation, ... Program Management, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management **The anticipated base pay range for this position is :** $196,000.00 - $342,700.00 Additional Description for… more
- Bristol Myers Squibb (Princeton, NJ)
- …documents + Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct + Represents Clinical Development ... in both internal and external forums as the consulted authority for the disease area, including within Business Development function + Partners with Worldwide Patient Safety physicians in the ongoing review of safety data + Serves as the (co-)leader of the… more
- Parexel (Trenton, NJ)
- …close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and ... in compliance with Client Procedural Documents, international guidelines such as ICH- GCP , and relevant local regulations and that the sites deliver according… more
- Parexel (Trenton, NJ)
- …study execution in accordance with applicable prevailing laws, Good Clinical Practices ( GCP ), and sponsor standards. The Sr. CRA is accountable for site management ... quality of investigator sites (eg patient safety, site quality and compliance with GCP ), to maintain investigator and site staff engagement and satisfaction, and to… more
- Parexel (Trenton, NJ)
- …close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and ... that site staff have completed and documented the required training appropriately, including ICH- GCP training, prior to and for the duration of the study. Ensures… more
- Fresenius Medical Center (Jersey City, NJ)
- …clinical trials under the direct supervision of the Principal Investigator (PI), Director , and other site personnel as applicable. Responsible for the collection and ... requirements as instructed by the PI and governed by Good Clinical Practice ( GCP ) and ICH guidelines, and assisting with ongoing study activity. PRINCIPAL DUTIES AND… more
- Eurofins US Network (North Brunswick Township, NJ)
- …functions as outlined in the GLPs and PSL SOPs. Assist the Quality Assurance Director as needed during inspections by EPA, FDA or clients. Prepare records and ... when advance notice is given and Sponsor and/or Laboratory Director approval is obtained. + Conduct in-process study inspections...Experience in other quality standards such as cGMP or GCP will also be considered. + Experience with acute… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …through early and/or late phase development. The Sr. Manager reports to the Director , Clinical Sciences and collaborates closely with Medical Director (s) (MDs) ... quality review + Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + Performs… more
- Vitalief (Livingston, NJ)
- …(depends on experience level) Responsibilities: + Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all ... staff, students, and IRB members. + Maintain compliance with OHRP, FDA, ICH/ GCP , and institutional regulations. + Manage IRB databases, tracking systems, and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …make a difference with. **The opportunity** The Clinical Trial Physician (CTP), Director , sits within Clinical Development and is responsible for contributing to the ... functional areas such as GCO, biostats, regulatory, pharmacovigilance. The Director will be a key contributor to INDs, NDAs,...+ Ensures clinical trials comply with clinical guidance, ICH, GCP , in agreement with the laws of the relevant… more