- Novo Nordisk Inc. (Plainsboro, NJ)
- …with pharmaceutical aggregate spend solutions and data associated with promotional and clinical data , preferred . Ability to manage multiple projects to ... interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Knowledge of CDISC and SDTM and industry standard data collection practices preferred - 7+ years Clinical data management experience in a medical ... Management, is accountable for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical...work alongside DS Procurement and DM operations to qualify preferred data vendors to ensure DSI … more
- Merck & Co. (Rahway, NJ)
- …with a strong emphasis on managing and applying Clinical Data Interchange Standards Consortium (CDISC) Controlled Terminology. Preferred Experience: C DISC ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data ... are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a ...structures and available tools to manage, extract, and report data is preferred .Fluent Oral and written English… more
- Tris Pharma (Monmouth Junction, NJ)
- …FUNCTIONS Actively participates in, or leads various aspects of preclinical or clinical data review including, but not limited to: adverse events, ... data management and safety management plans Ensures clinical data collection proceeds in a manner...Special knowledge or skills needed and/or licenses or certificates preferred :Advanced degree (MS, MPH, PhD, PharmD, etc.) Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lifecycle - Collaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify ... This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population...Qualifications10 or More Years with PharmD, PhD and relevant clinical experience preferred 10 or More Years… more
- Novo Nordisk Inc. (Atlanta, GA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to new systems. Working knowledge of electronic trial master files and clinical trial systems and portals preferred Excellent communications skills (verbal, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree preferred A minimum of 10 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key ... around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...to make a difference? The Position Use medical and clinical expertise in design, implementation and monitoring of … more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... Lead and provide statistical support for related drug/vaccine projects in Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical … more
- Merck & Co. (North Wales, PA)
- …conflict resolution expertise and discretion. Preferred : Cross-functional experience in clinical research (eg, monitoring, data management, clinical ... data (eg our company's IT data hub - InForm, DMW, Clinical Data Repository (CDR), Site Management Authoring and Reporting Tool (SMART) and others if… more
- TalentBurst, Inc (New York, NY)
- TalentBurst, Inc is seeking a travel Clinical Research Coordinator for a travel job in New York, New York.Job Description & RequirementsSpecialty: Clinical ... as applicable. Conceptually applies the research protocol to the clinical setting to allow accurate and timely completion of...the study monitor to review, verify and correct all data entered onto the case report form and to… more
- Adara Home Health (Hutchinson, MN)
- Our Mission: Honoring PeopleOur Values: Integrity, Compassion, Curiosity, and HelpfulnessThe Clinical Supervisor is responsible for directing the clinical ... activities of assigned clinicians at a company location; planning clinical services to clients and conferring with employee to ensure services are provided at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …+ years of experience with Clinical Trials Data , Genomics, Bio Marker & Regulatory Data preferred - 4 or More Years 4 + years of experience with data ... data capabilities like Data Lakes, Master Data Management, NLP Integrations etc. for Clinical ,...such as flat files, databases, xml files and/or unstructured data & web services preferred - 4 or… more
- The University of Vermont Health Network (Plattsburgh, NY)
- GENERAL SUMMARY: The Clinical Pharmacy Manager is responsible for the design, planning, implementation and maintenance of all Clinical Pharmacy programs. This ... improvement, evidence based practice, patient focused care and informatics. The Clinical Pharmacy Manager also assists the Director with organizational planning,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and data management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical , product, and vendor data ... Experience with data capabilities such as modern data catalogs, metadata managers and lineage capabilities. preferred...CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting… more
