- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project ... (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus...Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader… more
- Merck & Co. (Rahway, NJ)
- …with the support and oversight of a Senior Clinical Data Manager (SCDM)/ Lead Clinical Data Manager (LCDM); issuing queries and follow up until ... responsible and accountable for the execution of the Merck clinical research portfolio. The Global Clinical... Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within… more
- Merck & Co. (Rahway, NJ)
- … Clinical Quality Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead establishes and/or - local clinical ... Job DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety, high quality data...-A minimum of 10 years of relevant experience in clinical research including direct field monitoring experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Data Science & Evidence (CDSE) department. Essential Functions Lead observational research projects and manage vendors, contracts and budget ... Position The Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) -...approvals and engage reviewers during approval process Responsible for data dissemination for specific research projects -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... trial processes and functions including experience in one or more clinical trial operations functions / sub-functions ( Data Management, Biostatistics, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lessons learned, and enterprise-wide best practices.Reinforce DS commitment to inclusive clinical research by conducting presentations and trainings, where ... and current awareness of the evolving global requirements for diversity in clinical trials -Continually evaluate industry landscape and lead identification… more
- Insmed Incorporated (San Diego, CA)
- …our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 ... effective scientific and administrative operations. Operates, maintains, and repairs clinical laboratory equipment within scope of training including routine… more
- Merck & Co. (North Wales, PA)
- …SummaryThis position contributes to the scientific planning and execution of one or more clinical trials. Assists the Lead Clinical Scientist and study team ... data collection is in alignment with the protocolCore SkillsWorking knowledge of clinical research regulatory requirements (eg, GCP and ICH)-Ability to manage… more
- Merck & Co. (Rahway, NJ)
- …operating in 47 countries, responsible and accountable for the execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management ... more clinical trials. You will assist the Lead Clinical Scientist and study team with...intends to: Develop an understanding of the phases of clinical research . Develop an understanding of the… more
- Merck & Co. (North Wales, PA)
- … data is collected from trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety profiling and ... data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data... Trial Organization to focus on what matters. -As Research and Development IT continues the transition from project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including experience in one or more key functions (eg, clinical research , clinical operations, data management, biostatistics, project management) ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Manager, Global… more
- Merck & Co. (Rahway, NJ)
- …enable new SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , you will be responsible ... for delivering SAP solutions to our Global Clinical Manufacturing user community. You will p articipate in...company's' stakeholders to capture user requirements and process flows, lead and participate in design, and build solutions with… more
- Merck & Co. (Rahway, NJ)
- …intellectually curious, join us-and start making your impact today.--Overview:-- -Merck Research Lab's (MRL) Pharmaceutical Sciences & Clinical Supplies (PSCS) ... Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research Laboratories portfolio… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a ... Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians...as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Insmed Incorporated (Bridgewater, NJ)
- …finalization of materials, and distribution to executive leadership.Manages vendor(s) for clinical trial data visualization dashboards to ensure accuracy of ... ownership of new reporting/dashboard system with support from IT and Clinical Systems Lead . Maintains ownership after implementation.Attends relevant external… more
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with...other clinical scientists.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in end-to-end clinical trial execution in one or more key functions (eg clinical research & development, clinical science, clinical quality ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Director,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Merck & Co. (North Wales, PA)
- …health economic and outcomes research experts worldwide Present outcomes research data at international/national congresses and publish articles in ... Job DescriptionUnder the guidance of a Senior Director, Outcomes Research (OR), the incumbent will have the primary responsibilities...Care. Specific roles include but are not limited to: Lead one or more Value Teams (VT) and provide… more
