- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to managing assigned clinical trials , document management and management of clinical trial management systems and archiving systems. ... start up through closure, including but not limited to: Management of clinical trial documents,... trials , including distribution of SUSARs to clinical trial sites Maintenance of systems, eg,… more
- Novo Nordisk Inc. (Atlanta, GA)
- …proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and ... the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project, MS… more
- Insmed Incorporated (Bridgewater, NJ)
- …the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ... status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual...process, including working knowledge of all functional areas of clinical trials and medical terminology, FDA and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …best practices within capacity planning, reporting and overall performance metrics for clinical trial reporting Physical Requirements Up to 10% overnight travel ... required; Advanced degree preferred A minimum of 10 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who ... of those principles to trial design, planning & conduct of clinical trials Deep understanding of Distributor, Logistics and Demand Planning Operations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immunology, or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus preferred ... employer including veterans and people with disabilities. Summary The Associate Director, External Data Management , is accountable...all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials ,… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in Computer Science, Statistics, Applied… more
- Merck & Co. (North Wales, PA)
- …knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control ... that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM ( Risk...GDMS, BARDS Statisticians and rest of members of the Clinical Trial Teams (including Country roles) to… more
- Tris Pharma (Monmouth Junction, NJ)
- …teams to mitigate issues in initiation and management of one or more clinical trials and monitor guidelines, IDMS charter, statistical analysis plans, data ... outcome measures, data review and support all appropriate manner of clinical trial activities. The incumbent primarily provides scientific, operational and… more
- Merck & Co. (North Wales, PA)
- …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills. Able… more
- Catalent (San Diego, CA)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... Quality Assurance Associate , Clinical SuppliesPosition Summary: Catalent Pharma...identify aberrant data and potential quality/compliance concerns escalating to management .Excellent written and verbal communications skills with internal and… more
- Merck & Co. (North Wales, PA)
- …country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management team.Review and ... the operational planning and execution of one or more clinical trials . In this position, you will...for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical … more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... and implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication… more
- Merck & Co. (North Wales, PA)
- …statistical analysis and high-quality data to assist decision making in clinical trials .-This position supports statistical programming activities for multiple ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck & Co. (Rahway, NJ)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to meet ... immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
