- 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 ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the assigned ... disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence... trial performance and quality metrics and share with study team, Operations Program Lead, and Sr .… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... documentsServes as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and can conduct/develop PK-PD… more
- Aequor (Thousand Oaks, CA)
- …include: ? Translate Toxicology, Pharmacokinetics and Drug Metabolism (PKDM) and Clinical Development study requirements into an actionable supply plan. ... timing, resourcing, and budget projections ? Determine distribution strategies for global studies . ? Articulate clinical supply chain management processes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role... Associate Director (or above) responsible for Operational Study Strategy. This position may require the Sr… more
- Aequor (Thousand Oaks, CA)
- …regulatory guidelines impacting supply (ie GxP, SOX) High attention to detail Understanding of clinical study conduct Ability to operate in a team or matrixed ... or Business experience preferably in the biotechnology or pharmaceutical industry OR Associate 's degree and 6 years of Life Science or Business experience preferably… more
- Merck & Co. (Rahway, NJ)
- …Respiratory projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical...development of assets within the Respiratory Section of Global Clinical DevelopmentMay serve as a senior therapeutic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director ( Sr . Principal Scientist) has primary ... The Senior Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, ... Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indications.Support as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document ... research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …KPIs, KRIs, KQIs across all RD LFs. Define Cycle Times, Identity key milestones at Study , Country, and Site Level to gauge clinical trial performance. Build and ... and roles. Candidate will be responsible for managing external Benchmarking Study Submissions and seeking out external competitive intelligence to provide line… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements for diagnostics and devices.Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, ... dossier documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for development of biomarker,… more
- Daiichi Sankyo, Inc. (Raleigh, NC)
- …informationIdentifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) ... research, academic or US managed markets preferredPrevious experience in Oncology, clinical research and medical education preferred Principal MSL/ Associate … more
- Novo Nordisk Inc. (Durham, NC)
- …May consider an Associate 's degree in chemistry or relevant field of study from an accredited university with a minimum of three (3) years of experience ... & processes in accordance with relevant project plans & timelines. Relationships Senior Manager, Quality Control - OFP. Essential Functions Accuracy & Scientific… more
- Eisai, Inc (Nutley, NJ)
- …and Analytics plus 2 years of work experience in job offered or as Senior Systems Analyst/Data Analyst/ Associate Projects. Also requires 2 years of experience ... from you.Application Programmer sought by pharmaceutical company in Nutley, NJ.Support clinical applications for clinical data management. Perform data review… more
- Abbott (Sacramento, CA)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Clinical Associate ** **About Abbott** Abbott is a global healthcare leader, ... in the following areas: + Sales support; + Regional training seminars; + Clinical studies /data collection; + Trouble Shooting; and, + New product in-service… more
- WuXi AppTec (Austin, TX)
- …position within the Operations team and is assigned as a study lead to manage clinical trial studies . The Senior CRA will partner with a Project Manager ... every disease can be treated." **Responsibilities** **Job Summary:** The Senior Clinical Research Associate is...teams, liaise with other functional areas to accurately coordinate clinical study activities + Coordinate clinical… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- …pancreatic or advanced solid tumor? We have a role for you! Job Duties: As a Senior Clinical Research Associate , you will monitor clinical trial programs ... study sites. + Effectively communicates with site study staff and Catalyst clinical research personnel...Field Monitor from the assigned Clinical Trial Associate . + Works closely with the extended study… more
- Abbott (Santa Clara, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This position of Sr . Clinical Research Associate works on-site at our ... location in the Hematology Division. This role will support/lead clinical studies for one of the Alinity...which may fluctuate depending on the phase of the study . The Sr . CRA is responsible for… more
