- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will ... including experience in one or more key functions (eg, clinical research, clinical operations, data management, biostatistics, project management) required-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... trial processes and functions including experience in one or more clinical trial operations functions / sub-functions ( Data Management, Biostatistics, … more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all programming ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data ... data review listings and reports to support Data Management and clinical teams.Develop, implement and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the ... Center for Data Governance (CFDG) execution of the change management efforts...in life sciences, pharma or informatics industry working with clinical trials, genomics / biomarkers, discovery, commercial, real world… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position is required to work within a team focused on process, data /insight packages, outsourcing, and innovation. Depending on business needs this position may ... (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility… 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)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 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
- 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 Overview ... The 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
- 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 ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing...plans, and addressing all regulatory, drug and patient safety, data , CMC, IP, patient selection, market acesss and and… more
- Actalent (Basking Ridge, NJ)
- This large, leading pharmaceutical is looking to hire a fully remote Senior Clinical Data Manager to their team of subject matter experts! Description: ... Clinical Data Manager who will work collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 quality + Participates in audits and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part ... The Senior Manager Clinical Scientist Hematology leads in...critical risks and mitigations + Promotes consistent first line medical/ clinical data review techniques and conventions across… more
