- IQVIA (Carlsbad, CA)
- … Research Associate! You'll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and ... phases as required. Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) per GCP/ICH and local… more
- Gilead Sciences, Inc. (Foster City, CA)
- …within Inflammation Therapeutic Area (TA), and oversee all biostatistics workstreams for clinical trials , assets evaluations, and regulatory submissions in the ... all departmental standards and processes regarding the conduct of clinical trials , statistical methodology, data analysis and...In depth knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance.… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ Lead ongoing safety signal detection, evaluation, and benefit-risk assessments across clinical trials and postmarketing settings. + Serve as the primary ... safety deliverables. + Ensure data integrity and compliance in safety databases and clinical trial systems. + Drive innovation in safety science, including the… more
- Parexel (Sacramento, CA)
- …7+ years experience in pharmaceutical/biotech clinical data management / Biometrics ( clinical trial data and/or Real World Data) + Medical affairs experience ... (Phase IIIB - IV trials experience); Late Phase Oncology + Strong project management...teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more indications. **Key Responsibilities:** + Provide Statistical leadership to late-stage oncology clinical trials : developing trial design options and ... of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and… more
- Pfizer (South San Francisco, CA)
- …within the atirmociclib program. This individual contributor will be responsible for supporting clinical trial (s) and lead sub teams in clinical development. ... The successful candidate should ideally have prior experience in clinical trials , supporting development programs, health authority interactions and demonstrated… more
- Amgen (Thousand Oaks, CA)
- …provide clinical input into safety and regulatory interactions + Interpret and communicate clinical trial data + Oversee the authoring of clinical study ... commercialization processes + Experience with developing study concepts for clinical development and clinical trial ...patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes +… more
- Pfizer (South San Francisco, CA)
- …the hematology program. This individual contributor position will be responsible for supporting clinical trial (s) and lead subteams in clinical development. ... The successful candidate should ideally have prior experience in clinical trials , supporting development programs, health authority interactions and demonstrated… more
- Pfizer (San Diego County, CA)
- …CDK4 program. This individual contributor position will be responsible for supporting clinical trial (s). The successful candidate should ideally have prior ... experience in clinical trials and supporting development programs. **ROLE...+ Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration… more
- Parexel (Sacramento, CA)
- …studies, as applicable and/or appropriate for the MD + Providing risk assessment of clinical trials for local sponsorship as needed with the support of the ... Lupus is preferred *Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience The ability to… more