- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and ... and manages risks at the project and/or study level as it relates to data capture and reporting. Establishes EDC standards for reporting to ensure quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders ( Clinical Operations, Clinical Biomarkers, QCP, etc.) for establishing data collection, data standards and data cleaning needs ... in line with agreed upon EFTs, eDTS, DS External Data Standards and Contract/SOW. Promotes Daiichi Sankyo...optimal approaches to support the collection of diverse external data types. Advises Study Data Manager… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labs or analysis labs in collaboration with relevant stakeholders including Data Management, Clinical Operations and QCP/CDx/ Clinical BiomarkersSupport ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the...quality control of marketing content in alignment with compliance standards Continued Improvement: Ensure pull-through of 'test and learn'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Rahway, NJ)
- …development, programming of edit checks, and scripts that facilitate the transfer of electronic data files into the Clinical Data Management System (CDMS). A ... clinical databases development or programming. Demonstrated technical proficiency in Clinical Data Management Systems (ie, Inform, Inform Architect, Central… 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
- 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...and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations.… more
- Aequor (Thousand Oaks, CA)
- Fully Remote - Any time zone - Flexible hours Manager will be interviewing candidates and deciding which role would be best suited. Open to recent grad or someone ... Ariba, C3, salesforce Role 1: More transactional - receiving contracts - data entry to c3 compliance system using templates, generating agreements, and processing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and support documentation and records to certify compliance with in-house specifications/ standards and GMP for all NNUSBPI products. This position has QA ... Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Description Exciting opportunity at MSK: Join our team as aClinical Data Standards Manager , Prostate Cancer Clinical Trials Consortium (PCCTC)! We're ... and manage clinical coding systems (eg, MedDRA, WHODrug). + Clinical Data Management and Data Standards : + Align the database with global data … more
- AbbVie (Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Clinical Data and Reporting Standards (CDARS) Manager proactively participates in ... the development of data and reporting standards in support of AbbVie's portfolio of clinical trials, and ensures AbbVie's conformity to CDISC standards … more
- AbbVie (Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Clinical Data and Reporting Standards (CDARS) proactively participates in ... the development of data and reporting standards in support of AbbVie's portfolio of clinical...clinical research experience + Experience leading development of standards for data collection, tabulation, analysis and/or… more
- WuXi AppTec (CA)
- **Overview** The Clinical Data Manager II performs clinical database setup, maintenance, and data quality control functions through database lock in ... programs, as required, working directly with the assigned project manager to provide data management support +...+ Expected to have good working knowledge of Good Clinical Practices and Good Clinical Data… more
- Digital Prospectors (Bedford, MA)
- ** Clinical Data Manager ** **Bedford, MA** **Job Type:** Contract **Recruiter:** Jaime Gunning (https://digitalprospectors.com/our-team/jaime-gunning) ... **Phone:** ### **Position:** Clinical Data Manager **Location:** Bedford,...ensuring the integrity and compliance of clinical data management processes in alignment with regulatory standards… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Data Sciences comprises of the Clinical Data Engineering (CDE) and Clinical Data Standards . While the Clinical Data Standards ... charge of your future at Takeda. Join us a Manager , Clinical Data Validation Engineer... standards for clinical operation and data flow, the Clinical Data … more
- Teleflex (NC)
- Manager , Clinical Data Management...management activities and interfaces with the rest of the Clinical Operations team to ensure that standards ... make a difference in patients' lives. **Position Summary** The Manager , Clinical Data Management executes...is a critical responsibility. Knowledge of Industry and regulatory standards with an ability to translate clinical … more
