- Merck & Co. (Rahway, NJ)
- …research portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO ... team meetings to develop an understanding of the different skills and expertise of data management within a clinical trial team-- - Benefits of Fellowship -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports).Leads and ... diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in a pharmaceutical, biotech company, or similar environment with extensive Clinical Data Management (CDM) and Standards experience, hands-on ... including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development, maintenance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position The Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting ... RWE and works closely with all colleagues in both the RWE and broader Clinical Data Science & Evidence (CDSE) department. Essential Functions Lead observational… more
- Merck & Co. (North Wales, PA)
- …the assurance of deliverable quality and process complianceFamiliarity with statistical and clinical data management conceptsPreferred Experience and Skills: ... with internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management , Clinical and other project stakeholders.-… more
- Merck & Co. (Rahway, NJ)
- …Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder ... cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiac, respiratory, metabolic,… more
- Merck & Co. (Rahway, NJ)
- …Support development of Protocol and related study materials (eg, ICF documents/amendments, data management deliverables). - May interact with internal and ... of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of...close out of clinical trials within a program.- Clinical trials provide the required data which… more
- Merck & Co. (North Wales, PA)
- …database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Merck & Co. (North Wales, PA)
- …degree (Master's, PhD) preferred but not required.10 years of relevant clinical trial management experience with demonstrated success required, ... Job DescriptionActing as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with… more
- Merck & Co. (Rahway, NJ)
- …impact today.--Overview:-- -Merck Research Lab's (MRL) Pharmaceutical Sciences & Clinical Supplies (PSCS) organization is responsible for translating a therapeutic ... a functional drug product optimized for patients and for ensuring the availability of clinical supplies for patients. Within the PSCS team is the Global Clinical … more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... from the world's biomedical literature in support of regulatory, clinical research, marketing, and legal functions.- Plans, organizes, monitors, coordinates,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in one or more clinical trial operations functions / sub-functions ( Data Management , Biostatistics, Clinical Science) preferred Travel:Ability to travel ... areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reporting into this position is the Advanced Analytics Lead, Rapid Analytics Lead, Data Strategy & Management Lead, Dedicated Dashboard Lead and Strategic ... (AI & Generative AI) and other advanced analytics capabilities, drive change management and establish a robust Enterprise Insights, Data and Advanced… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical ... (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection... Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to: Global Clinical Operations, Global Regulatory Affairs, Biostatistics and Data Management , Epidemiology, Patient Advocacy, and Global Oncology Medical ... Analysis and Reporting:- Collaborate with the Biostatistics and Data Management (BDM) teams to develop metrics...(KPIs) to analyze and report on diversity metrics in clinical trials- Monitor data and regularly communicate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies from end to end in collaboration with Physician Scientists and the study team ( data management , clinical operation and other functions) to implement ... in one or several programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management , Regulatory Affairs and other RD functions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical operations experience in trial diversity and patient access and/or clinical operations project management preferably with a sponsor company at a ... and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
