- BeOne Medicines (San Mateo, CA)
- …and simplify complex systems. Highly effective in analytical and strategic assessment of GCP compliance risks; able to articulate potential business impact. + ... matter expert or reviewer of initiatives and solutions to ensure compliance with ICH GCP , applicable laws and regulations and consistency within BeiGene Quality… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …development of global quality improvement initiatives. + **Training & Guidance** : Provide GCP compliance training and guidance to internal teams and external ... and reporting on global audits to ensure **Good Clinical Practice ( GCP ) compliance ** across Contract Research Organizations (CROs), clinical laboratories,… more
- Parexel (Sacramento, CA)
- …serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH- GCP compliance issues to Local Management and/or Clinical Quality Management ... monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH- GCP… more
- System One (Alameda, CA)
- …enjoying the beautiful San Francisco Bay Area backdrop! Job Description: The Quality Compliance Specialist GCP /GVP QA is accountable for Good Clinical Practices ... Job Title: Temporary Quality Compliance Specialist Location: Alameda, CA Type: Contract Compensation:...you have a commanding background in Good Clinical Practice ( GCP ) and thrive on ensuring regulatory integrity, this is… more
- System One (Walnut Creek, CA)
- …+ Supervise sub-investigators, research coordinators, and clinical staff to ensure GCP compliance . + Oversee investigational product management, including drug ... This PRN role ensures that all study activities are performed in compliance with ICH- GCP , FDA, and institutional standards, prioritizing participant safety,… more
- Parexel (Sacramento, CA)
- …serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH- GCP compliance issues to Local Management and/or Clinical Quality Management ... monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and… more
- Terumo Neuro (Aliso Viejo, CA)
- …including selection, initiation, monitoring, and close-out with strong regulatory and GCP compliance . + Collaborate with Medical Affairs, Clinical Quality ... Management. Ensure high standards of patient safety, data quality, and regulatory compliance while supporting the development and growth of the clinical research… more
- Ascendis Pharma (Palo Alto, CA)
- …Ascendis Pharmacovigilance System Master File (PSMF) + Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation ... are processed in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business… more
- Bristol Myers Squibb (Brisbane, CA)
- …(input on inclusion/exclusion and other safety-related clinical considerations) * Fulfills GCP and compliance obligations for clinical conduct and maintains ... Review Committee, support of Business Development activities and Quality and compliance leadership. The Clinical Trial Physician sits within Clinical Development,… more
- Bristol Myers Squibb (San Diego, CA)
- …and submission documents + Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct + Represents Clinical ... Target Product Profile (TPP) + Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues… more