- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...in accordance with DS standards. Act as the project manager of the clinical study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical ... in planning and execution of clinical studies , under...issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and execution of clinical studies , under the close supervision of a Manager (or above) within Clinical Operations , in adherence to the protocol, Good ... to the TMFConfirm Essential Document Listing accuracy throughout duration of trialProvide clinical administrative support to the study teams. This may include… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations . This position develops SAE ... to execute study start up processes.ResponsibilitiesGlobal PV Operations Representation on Clinical Study ... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Merck & Co. (Rahway, NJ)
- …progressive on-the-job training and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ... join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global...for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary… more
- Merck & Co. (North Wales, PA)
- …operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary supplies planning/tracking, ... team members.May interact with internal and external stakeholders (eg, study team, vendors, committees) in support of clinical...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has ... to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations , responsible for representing the GCO-CQM inspection ... to regulatory guidelines, and quality management principles. requiredExpert knowledge in Clinical Operations Phase 1 to 4 Trial Execution. requiredOncology… more
- Merck & Co. (Rahway, NJ)
- …Lead Clinical Scientist and study team with the scientific conduct of clinical studies . In this position, you will have the opportunity to develop your ... country operations , committees, vendors) in support of clinical study objectives. - Support development of...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager… more
- Merck & Co. (Rahway, NJ)
- …for the execution of the Merck clinical research portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management ... study sites, vendors, committees, etc.) in support of clinical study objectives.--You will be part of...and operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project… more
- Novo Nordisk Inc. (WA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational ... required Experience Qualifications4 or More Years clinical operations experience with strong preference for study ...with strong preference for study feasibility, and/or study design optimization and/or clinical operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan Ministry of Health, Labor… more
- Northeast Georgia Health System, Inc (Oakwood, GA)
- …Manages both the Sourcing and Procurement teams in daily operations , monthly budgetary oversight, and staff management. Minimum Job QualificationsLicensure ... Requirements: Bachelors Degree in healthcare, business, or similar applicable area of study .Minimum Experience: Minimum five (5) years experience in supply chain or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director, and Field Medical Affairs point to… more
- Merck & Co. (Rahway, NJ)
- …lockout/tagout and hazardous energy control procedures.- Support mechanical aspects of clinical operations , including support/initiation and gatekeeping of work ... Job DescriptionPosition Description: Specialist, Sterile Engineer This Sterile Pharm Operations Engineer position will provide engineering support to sterile … more
- Taiho Oncology (Princeton, NJ)
- Sr. Study Manager , Clinical Operations Princeton, NJ, USA Req #375 Tuesday, June 4, 2024 Looking for a chance to make a meaningful difference in the ... support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring...as well as overall day-to-day operations of clinical studies , ensuring study information… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ability to deliver live changing therapeutics to those in need._ ** Clinical Trials Manager , Clinical Operations - Oncology (CTM)** **We are seeking a ... Gilead and help create possible, together. **Job Description** **_CLINICAL OPERATIONS_** _: Clinical Operations is responsible for the execution of all Phase… more
- Abbott (South Portland, ME)
- …working mothers, female executives, and scientists. **The Opportunity** The position of ** Manager , Clinical Operations ** is within our Infectious Disease ... in **South Portland, Maine** . In this role, the ** Manager , Clinical Operations ** will oversee...will oversee the design, implementation, and monitoring of global clinical studies of new and modified in… more
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