- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the absence of Asset Lead ).-Where appropriate, may delegate certain responsibilities to Study Manager (s) assigned to the study - Protocol Development, and ... insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in...study team list is maintained.-In partnership with the lead physician, Clinical Scientist and all … more
- Insmed Incorporated (NJ)
- …competencies.Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead , and clinical study team to ensure ongoing ... future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for...cost, and timeline parameters.Effectively manages and/or assists with cross-functional clinical study team and team members to… more
- Formation Bio (New York, NY)
- …quality, cost control, and on-time deliverables. Serve as the Operations Lead for clinical assets and associated studies . Step in as the Clinical Project ... Oversight Provide strategic and tactical guidance for ongoing and newly launched clinical studies , ensuring alignment with corporate and asset development goals,… more
- BioAgilytix (San Diego, CA)
- …while you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support ... of preclinical, clinical , and product release studies for our... (BPM)/Principal Investigator (PI) for all assigned clients and studies . Lead regularly scheduled client meetings to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role ... OverviewThe MES Project Manager will be part of Manufacturing Science and Technology...and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management… more
- Genmab (NJ)
- …you and feel like a fit? Then we would love to have you join us! Manager , Statistical ProgrammingHands-on support of clinical trial reporting; Leading a team of ... in scope for this position.Responsibilities include: Review and input into key study level documents including CRF, SAP, table shellsDrive development of ADaM… more
- Insmed Incorporated (NJ)
- …Clinical /Manufacturing systems.Project lead experience preferred.Strong experience in Clinical Study Systems is required.Experience in evaluating and ... and FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental… more
- ACROBiosystems Inc. (San Jose, CA)
- …validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies , commercial production, and companion diagnostics. We ... cross-functional collaboration and continuous learning. Job Summary The Associate Regional Manager will lead commercial activities across Northern California,… more
- BeOne Medicines (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study ... Study Report in collaboration with Global Clinical Study Manager and Medical...biotech, pharma or CRO industry + Proven experience in clinical research including relevant experience as team lead… more
- Parexel (Olympia, WA)
- Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical ... Management** Study Team Support + Supports individual clinical study teams as required for all...Acquisition and Management + Works closely with data management lead to determine how sample and testing data will… more
- BeOne Medicines (Emeryville, CA)
- …_Line management responsibilities:_ + Provides leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio ... of the business are met. + Contributes to overall Clinical Operations strategy for the region and is accountable...Solid leadership and management experience either as direct line manager or as cross functional team lead … more
- GRAIL (Menlo Park, CA)
- … Clinical Operations. **Responsibilities:** + Serves as the Clinical Operations Study Lead for assigned studies , providing strategic and operational ... are using the power of next-generation sequencing (NGS), population-scale clinical studies , and state-of-the-art computer science and...trials, with at least 2 years experience in a Clinical Operations study lead role,… more
- Organon & Co. (Jersey City, NJ)
- …TMED studies . **Responsibilities** + Manage and support the operational aspects of clinical studies from study start-up through close-out. + Manage and ... **Job Description** **The** **Position** The Clinical Trial Manager (CTM), Translational Medicine...TMED Operations Lead to plan and execute studies including, but not limited to, managing study… more
- Terumo Neuro (Aliso Viejo, CA)
- **13038BR** **Title:** Sr Manager , Sales & Clinical Training **Job Description:** Responsible for designing, facilitating, and advancing training initiatives ... that elevate the performance of the company's sales and clinical teams. Lead programs that integrate selling...and San Francisco Fair Chance Ordinance. **External-Facing Title:** Sr Manager , Sales & Clinical Training **Posting Country:**… more
- BeOne Medicines (San Mateo, CA)
- …related Depot performance management in AMER regions. + Work with Supply Chain Lead and depot PM setting up distribution and return/destruction procedures for ... studies following the logistics related procedures. + Coordinate drug...brings compliance issues to the attention of management. + Lead and measure processes to ensure logistics operations are… more
- BeOne Medicines (San Mateo, CA)
- …+ Experience in clinical operations as clinical research associate, clinical study manager , or compliance required **Computer Skills:** + ... learning and development strategy for GCO new hires including Clinical Research Associates, Clinical Study ... Operations to identify training needs and priorities. + Lead the creation and/or maintenance of GCO Onboarding training.… more
- BeOne Medicines (Emeryville, CA)
- …with general and study -specific monitoring issues - Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review ... a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance… more
- Stony Brook University (Commack, NY)
- …patients participating in research. There are approximately 10 active and ongoing research studies . The Clinical Services Administrator is key to the success of ... and productivity metrics are met for all teams. + Lead workshops, meetings, trainings. Effect change where needed. Improve...and train new clinic staff. Provide guidance to Nurse Manager on clinical staff performance. Oversee and… more
- BeOne Medicines (Emeryville, CA)
- …to join the Scientific Programming team. The successful candidate will lead programming activities to support real-world evidence (RWE) generation using large-scale ... analysis-ready datasets, tables, figures and listings for observational and RWE studies derived from diverse real-world data sources, including claims, electronic… more
- Parexel (Bismarck, ND)
- …assigned project/ study . + Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), ... - Medical Support / Medical Monitoring for projects and studies contracted to Parexel - Deliver all medical support...task contracted) and according to the assigned role (Global Lead Physician GLP or Regional Lead Physician… more
