- University of Pennsylvania (Philadelphia, PA)
- …required obligations to patients/subjects, Principal Investigator (PI), study team and Sponsor/ CRO . This position will report directly to the Program Manager and ... the study team and facilitate eligibility review with the Sponsor/ CRO , if required. + Provide support to faculty and...+ Collect, review and report timely, valid, and accurate data within the timelines specified by the study-specific Agreement;… more
- Genentech (South San Francisco, CA)
- …the deployment/ outsourcing of these methods to external Contract Research Organizations ( CRO ), and the generation of regulated bioanalytical data for ... eg Translational Medicine; + Oversight over the generation of foundational bioanalytical data (internally or through CRO ) for nonclinical and clinical… more
- University of Pennsylvania (Philadelphia, PA)
- …of biological samples and related study documents, and collection of clinical data . Assist with Institutional Review Board (IRB) filings and inquiries, and assist ... clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry + Coordinate IRB submissions and renewals in accordance with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure appropriate design, statistical analysis and reporting of Gilead clinical data in efficiently achieving regulatory, scientific and business objectives. The ... collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …Startup. + Champion the creation and implementation of innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued SB&C ... management, mentoring, and development of assigned SB&C staff. + Partners with CRO 's, Clinical Operations teams, and TAU partners to improve overall SB&C metrics… more
- Cordis (Irvine, CA)
- …in clinical studies including device training, case support and ensuring timely data collection for clinical programs. **Job Functions:** + Perform Physician and ... in site selection, site initiation and activation, supporting cases, ensuring quality data acquisition throughout follow up and performing study closure activities +… more
- ThermoFisher Scientific (Wilmington, NC)
- …HIGHLY preferred **Experience level:** Global CTM experience, highly experienced in CRO and monitoring oversight, with strong vendor management skills. Onsite ... Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study...the start of a trial. + Support the Clinical CRO in the training of the CRAs on all… more
- ThermoFisher Scientific (Wilmington, NC)
- …risk management plans are in place** **Provide oversight/support/guidance to Strategic partners/ CRO to ensure study issues are addressed and resolved rapidly** ... managed by Strategic Partner and/or other CROs** **Oversee Strategic Partners/ CRO /vendor selection, budget and contract negotiation, and proper supervision of… more
- CSL Behring (King Of Prussia, PA)
- …strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions + Influence and ... the responsible program. Ensure timeliness and quality of deliverables by CRO /FSP. + Support or lead improvement initiatives within the department, organization… more
- CSL Behring (King Of Prussia, PA)
- …strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions + Influence and ... the responsible program. Ensure timeliness and quality of deliverables by CRO /FSP. + Support or lead improvement initiatives within the department, organization… more