- Merck & Co. (Rahway, NJ)
- … Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing queries ... portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO organization. GDO focuses on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end… more
- Eisai, Inc (Nutley, NJ)
- …in a wide range of security issues including architectures, firewalls, electronic data traffic, and network access. Researches, evaluates and recommends new security ... of record, differentiation and innovation). Establishes and enforces secure and consistent data exchange standards with third parties based on data sensitivity.… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary Monitor Security Threat Intelligence Data and Feeds:Regularly monitor security threat intelligence sources and feeds to stay ... updated on emerging threats, vulnerabilities, and attack techniques.Analyze threat data to identify potential security risks and assess their potential impact on… more
- Eisai, Inc (Nutley, NJ)
- …on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support ... Requirements Bachelor's degree in associated functional disciplines including IT, Data Sciences and others.Software development familiarity with both Agile and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... internal statistical programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and ... position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working knowledge… more
- Eisai, Inc (Nutley, NJ)
- …compliance with GDPR, HIPAA, CSL, and other relevant security and data privacy standards. Your responsibilities span security operations, risk assessment, ... US's compliance with GDPR, HIPAA, CSL, and other relevant Security and Data Privacy standards through continual risk and security assessment.Collaborates with global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …statistical analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data . Work closely ... protocol development, CRF review, SAP development, analysis files development, data surveillance review, statistical analysis accuracy validation, results interpretation… more
- Aequor (New York, NY)
- …lines across GCS. Use technical operational and Clinical Development portfolio data to analyze and interpret past results, perform variance analysis, identify ... relationship and risk management, this role requires significant use of systems and data analysis, to ensure business operation information is delivered in a timely… more
- Lundbeck (Queens, NY)
- …neurology and psychiatry. Join us on our journey of growth!As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our ... Planning & Account Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics, allocate resources to… more
- Merck & Co. (Rahway, NJ)
- …to ensure the integrity and consistency of the data .Compare independently entered data and collaborate with the Clinical Research Manager (CRM) to resolve ... supported. However, some common responsibilities and functions include:Write study-specific data management plans and reports.Develop and maintain databases to… more
- Merck & Co. (Rahway, NJ)
- …and roadmap, translating business strategy into short- & long-term technology and data needs ensuring the business is fully enabled by IT capabilities, including ... operations (MS&O).Enterprise IT is searching for an energetic and experienced IT Program Manager and Scrum Master to support the IT Product Line Lead for Learning… more
- Lundbeck (Bronx, NY)
- …and psychiatry. Join us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and ... Planning & Account Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics, allocate resources to… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 integrity- Oversee statistical programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the ... oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act as PV… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in support of benefit risk profile throughout product lifecycleIndependently evaluates safety data of any source to identify potential safety signals, tracks safety ... Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)Contributes to regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... in one or more clinical trial operations functions / sub-functions ( Data Management, Biostatistics, Clinical Science) preferred Travel:Ability to travel up to… more
- Merck & Co. (Rahway, NJ)
- …close out of clinical trials within a program.-Clinical trials provide the required data which allows Merck to bring new prescription medications and vaccines to the ... project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ProjectYou will partner with CSSM team members to train on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Proactive Auditing and Collaborative System Upgrades Conduct in-depth audits of payroll data , collaborating with HR and IT to not only address discrepancies but ... This includes liaising with HR Benefits Team and vendors, correcting data discrepancies, and streamlining processes for efficiency. Comprehensive Training on… more
