- Abbott (Alameda, CA)
- …Communicates with and provides updates to specific core teams. + Oversees activities delegated by Sr . Clinical Research Manager or Sr . Director, ... working mothers, female executives, and scientists. **The Opportunity** The Clinical Manager is responsible for managing and...provides ongoing updates, and presents project results to Division senior clinical management. + Assists in the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …able to adjust workload based upon changing priorities + Meets all requirements for Clinical Trial Manager (CTM) position with demonstrable proficiency. The ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and ultimately our ability to deliver live changing therapeutics to those in need. Clinical Trials Manager , Clinical Operations - Oncology (CTM). ... is responsible for the execution of all Phase 1-4 clinical trials , across all therapeutic areas, around...Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance… more
- BeiGene (Emeryville, CA)
- …updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:**… more
- US Tech Solutions (Foster City, CA)
- … clinical or related experience in life sciences. * Meets all requirements for Senior Clinical Trial Management Associate ( Senior CTMA) grade 26 ... required with the collection, delivery and analysis of **biological specimens** within a clinical trial * Provides **sample management** expertise to the Study… more
- IQVIA (Berkeley, CA)
- …Functionally responsible for all team members throughout the duration of each clinical trial . Assures clear client communication, process documentation, and ... to manage multiple priorities within a variety of complex clinical trials * Ability to reason independently...health-related field with at least five (5) years direct clinical trial experience in a CRO or… more
- ThermoFisher Scientific (San Francisco, CA)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver... clinical research services provide end-to-end support for clinical trials from study start up to… more
- BeiGene (Emeryville, CA)
- …with CRAs to ensure data collection is met per contractual guidelines * Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to ... Familiar with industry CTMS and data management systems **Other Qualifications:** * Understands clinical trial processes with a thorough knowledge of ICH and… more
- Abbott (Alameda, CA)
- …required. + Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations. + Experience in conducting medical device ... for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively...management. + Solid understanding and demonstrated experience of the clinical trial process including study design and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Manager , Biostatistics - Clinical Drug Dev - ... technical and operational statistical activities for a group of clinical trials . + Is a point of...through management of internal and external resources. + Provides senior level review of various technical documents. + Excellent… more
- Gilead Sciences, Inc. (Foster City, CA)
- …timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical ... technical and operational statistical activities for a group of clinical trials . Directs internal and external teams...analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring. + Uses a variety… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Sr Manager , Statistical Programming** Key Skills: + Successfully interacts ... basis. + Viewed as a key resource by more senior individuals on technical initiatives for projects and may...skills are required. + Has a thorough understanding of clinical trials design and reporting process, as… more
- AbbVie (South San Francisco, CA)
- …submissions to health authorities (HAs), including Investigational New Drug (IND)/ Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure ... to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Interpret FDA/European… more
- Edwards Lifesciences (Oakland, CA)
- …biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for clinical trials assigned to direct reports ... us and be part of our inspiring journey. As ** Senior Manager , Biostatistics, TMTT** , you will...the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA… more
- BeiGene (Emeryville, CA)
- …consistency across the organization + Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other ... scientific or healthcare discipline with 14+ years' experience in clinical trial industry + Both Project and...years of leadership and people management experience at managing senior manager level above persons, and experience… more
- BeiGene (Emeryville, CA)
- …Data Management, and other BeiGene Research Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for ... procedures, and external regulatory requirements. Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.… more
- Catalent Pharma Solutions (South San Francisco, CA)
- ** Senior Manager , Global Process Owner, Order...sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... for Highly Potent Active Pharmaceutical Ingredients (https://www.catalent.com/oral-dose/highly-potent-active-pharmaceutical-ingredients/) . The ** Senior Manager , Global Process Owner, Order to… more
- BeiGene (Emeryville, CA)
- **_General Description:_** The Senior Manager , GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase ... knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations + Ensure all logistics are… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of these tasks if outsourced. You will provide safety science input into clinical trial protocols, develop appropriate regulatory responses, and provide the ... from third parties, such as regulatory agencies. + Performs safety reviews of clinical trial protocols, Investigator's Brochures, clinical study reports,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** ** Senior Manager , Statistical Programming (Oncology)** **Job Responsibilities and ... skills are required. + Has a thorough understanding of clinical trials design and reporting process, as...timeframe. + Viewed as a key resource by more senior individuals on technical initiatives and may represent the… more