- Abbott (Alameda, CA)
- …branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Lead Clinical Risk Management Analyst** **Working at ... for diversity, working mothers, female executives, and scientists. **The Opportunity** The Lead Clinical Risk Management Analyst is responsible for… more
- Abbott (Pleasanton, CA)
- …restore their health and get on with their lives. As the Quality Engineer II Risk Management , you will Works closely with cross functional teams to establish and ... ensure compliance and quality for product related risk management documentation. Perform risk assessments and evaluations for products that conform to… more
- BeOne Medicines (Emeryville, CA)
- …Report in collaboration with Medical Writing and relevant CST members **Quality and Risk Management ** + Monitors study activities to ensure compliance with the ... (CST) meetings** **Planning and Execution** + Leads planning and management of the assigned clinical study(ies) from...operations methodologies, in depth understanding of all aspects of clinical study processes + Able to independently lead… more
- BeOne Medicines (Emeryville, CA)
- …supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Represents Clinical Supply Chain to internal ... **General Description:** The Manager of Clinical Supply Chain manages drug supply activities related...minimize waste while identifying risk and develop risk mitigation plans + Lead cross functional… more
- BeOne Medicines (Emeryville, CA)
- …Contributes to the design and implementation of risk identification and management strategy for clinical studies and other regulated drug development ... and GDP compliance matters. This role reports to the Senior Director, Global Clinical Operations Compliance Lead . **Essential Functions of the Job:** +… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director of Digital Clinical Operations Data Products Head is a member of the Digital GCO Leadership Team, responsible for implementing ... and analytics strategy with the goal to increase Global Clinical Operations' related productivity and aid in data driven...thoughtful use of technology and innovation + **Data Pipeline Management ** : Works with technology partners to create and… more
- BeOne Medicines (Emeryville, CA)
- …Description:** The SCRA is primarily a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data ... clinical staff. **Supervisory Responsibilities:** * Provides site level management for established protocols and portfolio under general supervision * Provides… more
- BeOne Medicines (Emeryville, CA)
- …reports, contributes to authoring of relevant sections + Actively leads the definition of Risk Management Plan (RMP) drivers & content, reviews core RMP & local ... Accountable for data requirement recommendations and safety section for clinical data management plan for capture during...matrix team to conduct robust safety assessments and safety risk management activities, based on ICH standards,… more
- BeOne Medicines (Emeryville, CA)
- …and manages approval of PSUR/PBRER responses to Has + Actively leads the definition of Risk Management Plan (RMP) drivers & content, reviews core RMP & local ... Accountable for data requirement recommendations and safety section for clinical data management plan for capture during...matrix team to conduct robust safety assessments and safety risk management activities, based on ICH standards,… more
- BeOne Medicines (Emeryville, CA)
- …for the resolution of issues on the studies within responsible program(s). + Lead the Global Clinical Study Managers (gCSMs) in designated programs while ... providing inspirational leadership, facilitating proactive risk and issue management , and delivering feedback-oriented...lead efforts to deepen scientific knowledge within the Clinical Operations' function. + Champion a global mindset and… more
- BeOne Medicines (Emeryville, CA)
- The Executive Director Breast/Women's Disease Area Lead , GMA, will support BeOne Medicine's Clinical and Medical assets by successful execution of Global Medical ... program. + Influence and support development of disease and product specific Clinical Development strategy within breast/women's cancers. + Lead with the… more
- BeOne Medicines (Emeryville, CA)
- …healthcare discipline + Minimum of 8 years of combined experience in Feasibility, Clinical Trial Management , Personnel Management and Operations ... **General Description:** The Global Strategic Feasibility Lead leads the development of Global Strategic Feasibility...feasibility teams. Close partnership with global program & study management team for design and delivery of the studies,… more
- BeOne Medicines (Emeryville, CA)
- …and marketing approval in global markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority ... lead execution of holistic regulatory strategy while considering risk /opportunity, timeline, resource. + Thorough understanding of drug development process and… more
- BeOne Medicines (Emeryville, CA)
- …He/she will also provide line management , people development, and performance management as well as support/ lead development and implementation of department ... and marketing approval in the NA markets, regulatory strategic development plans and risk assessments, critical issue management and advice on FDA interactions.… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** + Lead and/or mentor the program management team for oncology clinical development lifecycle management . + Develop and lead ... ensure global cross-functional alignment. + Implement good project and risk management practices. + Manage process for...track action items and progress reports according to project management best practices. + Lead process improvement… more
- Alameda Health System (Oakland, CA)
- …for the recruitment, orientation, evaluation, counseling and disciplinary action of care management clinical and administrative staff. + Responsible to purchase, ... to new equipment and/or techniques. + Review cases regularly with staff; acts as clinical consultant regarding care management issues; guides clinical staff… more
- Alameda Health System (Oakland, CA)
- Director, Utilization Management + Oakland, CA + Highland General Hospital + SYS Utilization Management + Full Time - Day + Nursing + Req #:40826-30155 + FTE:1 + ... Overview:** Alameda Health System is hiring! The Director of Utilization Management holds a critical role encompassing operational oversight, strategic planning,… more
- BeOne Medicines (Emeryville, CA)
- …requirements for clinical studies. + Partners with the global procurement management to build a strategy for comparator sourcing in support of the organization's ... The Director of Comparator Purchasing, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain vision and strategy providing leadership… more
- BeOne Medicines (Emeryville, CA)
- …Director (ex-China) for Hematology GMA will report directly to the Vice President, Hematology Lead for GMA. Under the direction of the VP, She/he will be responsible ... medical strategy for BeOne Hematology assets. The primary focus will be to lead and ensure execution of all programs and functions associated with BeOne Medicine's… more
- Bayer (Berkeley, CA)
- …Quality Systems (Deviation and CAPA management , Change Control, Audit & Observation management , Risk Management , etc.) + Expertise in cGMP and regulatory ... potential impact/ risk and product disposition; + Use the Discrepancy Management system/database and RCA tools at an expert level to perform comprehensive… more