- Beth Israel Lahey Health (Burlington, MA)
- …research staff and Research Administration facilitating all aspects of assigned clinical trials. Interacts with study participants diagnosed with various medical ... and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA, OHRP and GCP regulations: + Ensures adherence to regulations. + Educates and mentors other… more
- Pfizer (Boston, MA)
- **POSITION SUMMARY** You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for ... program. + Responsible for scientific oversight, data integrity and quality of the clinical trial(s). + Authors...of the sponsor leading studies + Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity… more
- Astellas Pharma (Cambridge, MA)
- …with other Medical Heads across Oncology and Biopharma/Cell&Gene and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and ... and Early Development and Translational Sciences, to ensure optimal strategic and quality input and delivery in planning of clinical development strategies,… more
- Teva Pharmaceuticals (West Chester, PA)
- …Managers (CPMs) and other GCO staff responsible for the timely execution of high- quality clinical studies within budget and according to SOPs. Manages the ... quality operational plans and activities with the overall Clinical Operations and Development Teams strategy while maintaining effective communication, including… more
- Vanderbilt University Medical Center (Nashville, TN)
- …in the Holowatyj Laboratory & Team, such that the integrity and quality of the clinical /translational research is maintained, the study objectives ... accomplished, and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy… more
- University of Colorado (Aurora, CO)
- **Research Services Information Sciences Professional (Open Rank: Entry Senior )** **Description** **University of Colorado Anschutz Medical Campus** **Department: ... Research Services Information Sciences Professional (Open Rank: Entry - Senior )** **Position #00837409 - Requisition #37384** **Job Summary:** **Key Responsibilities… more
- Gilead Sciences, Inc. (Foster City, CA)
- …SOPs, company policies and regulatory guidelines to provide timely and high- quality clinical data that supports global registration and commercialization ... process improvements and SOPs. + Meets all requirements for Senior Clinical Trial Manager ( Senior ...for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice ( GCP ) governing the conduct of… more
- CSL Behring (King Of Prussia, PA)
- …Lead People * Develop culture that enables successful recruitment and retention of high- quality Clinical Development Operations staff * Create a culture of high ... The Position: The Vice President, Clinical Development Operations will have overall strategic and...assess operating procedures and take action to drive on-going quality improvement * Strategically partner with key internal and… more
- IQVIA (Spartanburg, SC)
- …source documentation based on protocol requirements that adhere to Good Clinical Practice ( GCP )/International Conference on Harmonization (ICH) documentation ... * Reports any deviations from normal research practices to senior staff and implement agreed changes in the study...time, within budget and according to application protocol requirements, clinical research regulations and quality standards *… more
- Abbott (Alameda, CA)
- …limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. **This position is ... trials. + Proactively and effectively communicate the status of clinical studies to management. + Ensures quality ...be flexible when priorities change. + Working knowledge of GCP , Clinical and Regulatory Affairs. + Proficient… more
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