- Novo Nordisk Inc. (WA)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… more
- Merck & Co. (Rahway, NJ)
- …CRM.Attend local Investigator Meetings if requested to.Interface with GCTO partners on clinical trial execution.Escalates site performance issues to CRM and ... company Standard Operating Procedure (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP.)As line manager , the role is critical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Merck & Co. (North Wales, PA)
- …clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams...with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to… more
- Merck & Co. (Rahway, NJ)
- …range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial Team, ... Clinical Development Finance Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist will:Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or more key ... other research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is preferred A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge… more
- Bristol Myers Squibb (Princeton, NJ)
- …Committees, Vendors, Contract Research Organizations, GCP Officer (China only) + Internal: Global Trial Manager (GTM), Clinical Trial Managers (CTMs) ... Research or related work experience. + Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or… more
- University of Colorado (Aurora, CO)
- …and manage long- and short-term strategic planning in direct support of ongoing clinical trial advancements and operations. + Manage strategic staffing for ... Associate Director or Director of Clinical ...to site teams and other stakeholders on phase 1 clinical trial protocols and standardized processes. +… more
- Georgetown Univerisity (Washington, DC)
- …Assurance (ORQA), Clinical Research Operations Office (CROO), Research Pharmacy + Clinical trial sponsors, auditors, and study monitors This position has ... intellectual inquiry and making a difference in the world. Requirements Regulatory Associate - Clinical Research Management Office - Georgetown University… more
- AbbVie (CA)
- …Trial Team(s) + Managing the project-related clinical development budget with the Clinical Trial Team and Project Manager + Ensuring that decisions ... Development Plan and is responsible for: + Ensuring alignment between the IEST, and Clinical Trial Team(s) + Developing the proposed clinical milestones with… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDCS leads the integration of collected ... the approval of Takeda products. Further, CDCS efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- … Manager . + Internal support is provided to the Field Monitor from the assigned Clinical Trial Associate . + Works closely with the extended study team ... Job Duties: As a Senior Clinical Research Associate , you will monitor clinical trial...including the Sponsor, Vendors, Data Manager (s), Statistician, Medical Monitor and other trial … more
- Merck (Columbus, OH)
- …+ Attend local Investigator Meetings if requested to. + Interface with GCTO partners on clinical trial execution. + Escalates site performance issues to CRM and ... company Standard Operating Procedure (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP.) As line manager , the role is… more
- Taiho Oncology (Princeton, NJ)
- …sciences is preferred. Knowledge, Skills, and Abilities: + 2 years of relevant clinical trial support or site management experience in the pharmaceutical, ... Study Associate I, Clinical Operations Pleasanton, CA,...to multi-task and effectively prioritize in order to ensure clinical trial goals. + Recognize potential obstacles… more
- ThermoFisher Scientific (Atlanta, GA)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures...study systems are updated per agreed study conventions (eg Clinical Trial Management System, CTMS). Performs QC… more
- Bristol Myers Squibb (Brisbane, CA)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial ... May support clinical development planning (collaboration with Clinical Development Lead/ Clinical Trial Physician... narratives + Provision of information required by Protocol Manager for development of trial budget, CRO… more
- Hartford HealthCare (Hartford, CT)
- …is primarily responsible for the overall design, conduct, and management of the clinical trial , the CRA leads, facilitates and coordinates all clinical ... at St. Vincent's Medical Center in Bridgeport, CT. The Clinical Research Associate will also work at...with meeting the goals outlined in the protocol and clinical trial agreement * Motivate others, monitor… more
- Amgen (Washington, DC)
- …quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory ... for a career you can be proud of. **Senior Manager , Clinical Quality** **Live** **What you will...processes for global and local study teams and all clinical trial sites who participate in Amgen… more
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