- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management ... Plan, Clinical Study Reports).Leads and drives the data review process in collaboration with the study team to ensure data qualityParticipates in audits and… more
- Genmab (Princeton, NJ)
- …authentic is essential to fulfilling our purpose. The Role & Department As the Senior Clinical Data Manager , you will be operationally responsible for tasks ... synopsis and/or a Clinical Trial Team (CTT) is assigned. The Senior Clinical Data Manager will represent Clinical Operations Data Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a project manager for other activities involving assigned product(s) or clinical studies, as neededQualifications: Successful candidates will be able to meet the ... This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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...difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and… more
- Eisai, Inc (NJ)
- …to contract negotiation and management. Collaborates with study teams, legal, finance, clinical planning, compliance, clinical quality, data protection, IT ... Suite#LI-TS1Eisai Salary Transparency Language:The base salary range for the Manager , Clinical Outsourcing is from :102,100-134,000Under current guidelines,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …such as Data Science, serving as a key contact point into the Clinical Data Science and Evidence (CDSE) Real World Evidence (RWE) team. Relationships The ... 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. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical , product, and vendor data and Identify and… more
- Insmed Incorporated (San Diego, CA)
- …are overseeing internal and external laboratories and liaising with the clinical team to manage clinical trial samples.ResponsibilitiesOversees daily operations ... analytical methods and reports, review and approval of protocols, data interpretation and evaluation, etc.Coordinate inventory monitoring, sample management, tests… more
- Option Care Health (Columbus, OH)
- …patients with acute and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health is re-imagining the ... the nursing department. Also assists with the scheduling of clinical staff to visit patients. Works closely with the...patient care. Performs other duties as required by Nurse Manager , Area Director of Nursing and/or Director of Operations.Job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset ... dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrityOversee statistical programming… more
- Merck & Co. (Rahway, NJ)
- …experience in project area of interest or strong scientific background.Understanding of the clinical development process, clinical study data and outcomes ... Job DescriptionUnder the guidance of the Director/Associate Director Pub Manager , facilitate development of and maintain publications plans in the assigned… more
- VITAS Healthcare (Columbus, OH)
- …RN, participation in Performance Improvement Project(s) (PIP)c. Registered Nurse, RN, gathering clinical data which is used for quality measuresc. Professional ... to practice outside of scope of license to the manager /supervisor3. Registered Nurse, RN, performs supervision of (VITAS employed...to a Hospice/Homemaker, the RN will document in the clinical record that: i. All factors pertinent to the… more
- Lundbeck (Akron, OH)
- …and psychiatry. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers...Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across various departments of Daiichi… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed ... of multiple myeloma.Legend Biotech is seeking a Sr. QC Data Reviewer as part of the Quality team based...related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Tris Pharma (Monmouth Junction, NJ)
- …portfolio of best-in-class ADHD medicines and an exciting pipeline of clinical -stage programs across Pain, Psychiatry, and Neurology. Our proprietary technologies ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...provide input on deal terms and creation of relevant clinical , regulatory, and commercial scenarios Prepare clear and concise… 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 ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
