- 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)
- …according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data ... requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical...Management Plan, Clinical Study Reports).Leads and drives the data review process in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing data collection, data standards and data cleaning needs for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during ... to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management...of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical device… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... clinical trial sites to support trial start-up strategies Provides system and device expertise to train and support clinical trial sites Ensures ongoing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as ... standards team as an extended part of committee. Advise Study Data Manager on complex vendor management...and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device… more
- Arthrex (Naples, FL)
- …, biomaterials and biomechanical professionals. Arthrex is actively searching for an Associate Clinical Study Manager to join the Orthopedic Research ... eTMF design, CTMS design, and user testing for assigned studies Respond to site inquiries for study -related...with protocols, case report forms, and information packets for clinical studies Assist with recruiting and qualifying… more
- Arthrex (Naples, FL)
- …final/report, and publication. The position will mainly focus on developing clinical study protocols and associated documents, facilitating protocol amendments, ... this job is to provide technical and medical writing support for clinical study projects.Essential Duties and Responsibilities: Perform comprehensive literature… more
- DivIHN Integration Inc (Chicago, IL)
- …at Time and a Half. Manage Phases I IV domestic and international clinical research studies . Responsibilities include protocol design and development, case ... 630 8471027 Divya | 224 369 2969 Title: Medical Manager Location: Remote role but need local to Illinois...Preferred: Good understanding and experience in the conduct of clinical trials or in medical research in the industry… more
- ConvaTec (Lexington, MA)
- …regulations. **Key responsibilities and authority:** + Proactively manage assigned clinical studies . + Support clinical study delivery across Clinical ... Role:** Provide operational expertise to ensure effective delivery of clinical studies across Convatec's Business Units. Reporting... device arena; min 4 years experience in clinical study management. + Prior line management… more
- Actalent (Golden Valley, MN)
- …years of related experience, ideally in a clinical research environment and/or in clinical study management. * Understanding of GCP and 21 CFR 812 Preferred ... clinical research environment * Experience with US and international based clinical studies Experience Level: Expert Level Description: Responsibilities:. *… more
- Stryker (Mahwah, NJ)
- …precision. **What you will do** As the ** Clinical Study Manager (CSM),** you will manage ongoing Investigator-Initiated Studies and/or Stryker Initiated ... by visiting stryker.com Stryker is seeking to hire a ** Clinical Study Manager ** to support...research strategy. + Develop and maintain overall dashboard of clinical and non- clinical studies , including… more
- Stryker (Cary, IL)
- …annually. More information is available at www.stryker.com We are currently seeking a **Senior Clinical Study Manager ** , to join our **Medical** Division. ... and expectations. **What you will do** As a Senior Clinical Study Manager , you will...manuscript/presentation preparation. + Provide budget input aligned to planned clinical strategy for clinical studies … more
- University of Michigan (Ann Arbor, MI)
- CLINICAL CARE COORDINATOR (Ventricular Assist Device ) Apply Now **Summary** To provide comprehensive professional nursing support in a multidisciplinary cardiac ... device supply and maintenance. Participate in ongoing research studies in compliance with federal and organizational regulatory guidelines. **Supervision… more
- Medtronic (North Haven, CT)
- … study administration or related experience + Clinical research/ study coordination experience at Medtronic or medical device industry + Experience ... **Careers that Change Lives** The ** Clinical Studies Support Coordinator IV** in...Life** . Provide project/program coordination and support to Global Clinical Study team . Maintains study… more
- University of Colorado (Aurora, CO)
- Clinical Science Program Manager - 33067...clinical research coordinators for a variety of drug, device and biologic studies conducted at the ... **School of Medicine | Department of Medicine** **Job Title:** ** Clinical Science Program Manager ** **Position: #00821011 -...clinical research coordinators for a variety of drug, device and biologic studies conducted at the… more
- Amazon (Sunnyvale, CA)
- …clear understanding of study lifecycle - Experience running virtual and/or remote Studies - Familiar with advanced concepts of clinical research - Excellent ... of the site to successfully manage and conduct the clinical study . - Coordinates activities with the...4 years of experience with site monitoring/ management for clinical studies . Masters degree preferred - Current… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Daiichi Sankyo and regulatory requirements. + Functional Expertise: + Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, ... requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical... Clinical Study Reports). + Leads and drives the data review… more
- Philips (Cambridge, MA)
- …of compliant clinical study execution practices throughout Philips clinical studies including research and testing of products involving human beings. ... Tool, Site Activation, Study Duration, Database Lock, Clinical Study Report, Studies monitored...types are preferred: observational retrospective data studies , device registry studies , or clinical … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …GCP, Industry guidelines, and Olympus policies and processes for the conduct of clinical studies . **Job Duties** + Maintain, and monitor Olympus GCP processes ... implementation of Quality processes audit and inspection readiness activities to ensure clinical studies are conducted in compliance with relevant Olympus… more
