- Merck & Co. (North Wales, PA)
- … scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in ... in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of… more
- Merck & Co. (Rahway, NJ)
- …scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical data /medical protocol deviations in ... in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality, completeness , and integrity… more
- Eisai, Inc (Nutley, NJ)
- … Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but ... user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of … more
- Daiichi Sankyo, Inc. (Bernards, 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
- Aequor (Thousand Oaks, CA)
- …for purpose dataset - plan, build, review with the end in mind (protocol - data collection - data review - analysis - archive) New Technology Design and ... leadership and accountability. Core Competencies: Technical Expertise: o Deep knowledge of clinical data management processes and systems (eg, EDC, CDISC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data ... the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions...design, all steps from database development to database release, data review and cleaning, database lock), to… more
- Eisai, Inc (Nutley, NJ)
- …an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years ... US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and oversee results of CQA audits of study...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …techniques Maintain up to date knowledge of the latest approved scientific and clinical data to engage in meaningful discussions with customers and address ... experience using sales data /call reporting software ideal Mastery knowledge of the clinical management of diabetes and the range of treatment options Must be a… more
- Genmab (NJ)
- …regional, national, and global Medical Affairs strategiesProvide insights/feedback on emerging scientific/ clinical data that enhance the value and appropriate ... through scientific exchange in a fair and balanced manner and provide clinical /scientific support for Genmab's pipeline.Domestic travel of approximately 50% will be… more
- Taiho Oncology (FL)
- …trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and ... and participate in scientific exchanges and interactions with identified KOLs Present clinical and scientific data on Taiho's products and relevant therapeutic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the compound.- Responsible for scientific communications and publications; interpretation of clinical data ; ensuring consistency of clinical content and ... information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… more
- Merck & Co. (North Wales, PA)
- …Clinical Study Design, Clinical Testing, Clinical Trial Management Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data ... knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and… more
- Eisai, Inc (Nutley, NJ)
- …to prepare medical affairs personnel to enter strategic and compliant discussions regarding medical/ clinical data on Eisai products. The AD assumes a leadership ... initiatives including treatment landscape training (disease state and Eisai product data , pre- clinical data , experiential training, "special topics"… more
- Genmab (NJ)
- …reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Genmab (NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review , and approval of data packages for Data … more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and other ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Eisai, Inc (Nutley, NJ)
- …knowledge and participate in scientific exchanges and interactions with identified KOLs.Present clinical , scientific and economic data on Eisai's products and ... and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data .Demonstrate full knowledge of and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customer and patient needs and goals Understands and effectively communicates appropriate clinical data to peers, stakeholders, influencers and customer decision ... identifies and prioritizes business opportunities based on understanding of customers and data within assigned account(s) and in alignment with market access and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically ... variables and processes, and build appropriate mitigations. Drive interface with Integrated Data Review , Data Surveillance, targeted source document… more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in ... Clinical Supply Chain Management, Clinical Testing, Clinical Trial Management, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented,… more
