- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 the defined,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study initiation, study conduct and oversight (study monitoring, tracking of clinical data ), database lock, creating Clinical Study Report , and submission to ... and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assessment from a physician's perspectiveMay provide clinical input into the eCRF (Case Report Form) design, participate in the UAT (User Acceptance Testing) and CCG ... (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable...a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study initiation, study conduct and oversight (study monitoring, tracking of clinical data ), database lock, creating Clinical Study Report , and submission to ... ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from a physician's perspective- May provide clinical input into the eCRF (Case Report Form) design, participate in the UAT (User Acceptance Testing) and CCG (CRF ... Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan-...a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF)… 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 ... 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)
- …analyze and report on diversity metrics in clinical trials- Monitor data and regularly communicate findings to senior leadership to make recommendations for ... and updates our trial diversity strategy and tactics as appropriate Leads the data acquisition that study teams will utilize to develop study specific clinical trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) ... dataset, identify data inconsistencies and support data review, review...up to 10% Daiichi Sankyo, Inc. is an equal opportunity/ affirmative action employer. Qualified applicants will receive consideration for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …supervision to solve complex study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical ... Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to medium complexity studies including study design,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …supervision to solve complex study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical ... Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies...on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …candidate will coordinate with other team members to timely perform research activities, analyze data and report results along with other lab duties. The ideal ... documentation, especially electronic lab notebook. Maintain GxP and EHS compliance. Analyze and report scientific data in a timely manner. Present results in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy. This position may lead a small team and will report to the Head of Forecasting/Business Analytics and Deal Valuations.Responsibilities Cross-functional ... valuation model, including sourcing and validation of key assumptions and data from global cross-functional teams (Marketing, RD, Finance, Supply Chain, etc).… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Provides oversight of activities performed by direct reports and ... relevant to project development plan, study design, statistical analysis, data display, results validation, interpretation and reporting to accelerate worldwide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure flexibility in the planning of global complex submissions. Responsible for direct report FY objective and goal setting, in addition to the development of ... all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings. Lead a cross-functional team within DSPD RD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to tracking quarterly LE and annual financial targets and create variances report . Maintaining vendor contracts, contractor data , and critical database ... to enhance efficiency and effectiveness.- Research and analyze information or data for trends, and variances to ensure acceptable business practices, procedures… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …according to standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation ... Ensure materials are available for production. Support the ongoing production schedule by: Report to work on-time and according to the shift schedule. Perform other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead (CSL)- Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project ... lead projects, and/or ensure proper medical oversight; Monitor and manage direct report 's performance in such roles, ensuring that there is proper understanding of… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …strong background in cellular immunotherapy, this role is for you. This individual will report to the Executive Director in R&D. This position will play a pivotal ... design and execute experiments, document, and interpret scientific results, present the data to cross-functional teams In vivo study design and assay development.… more
- Develon (Suwanee, GA)
- …Parts Business' short/ mid/ long term business direction/ strategy through data reporting and analysis. Additionally, the successful candidate will drive key ... activities to further develop DEVELON brand and increase DEVELON Parts revenue. Data management, reporting, and analysisRun regular reports and align these reports… more
- Upward Health (Atwater, CA)
- …health requires care for the whole person. It's no wonder 98% of patients report being fully satisfied with Upward Health!What you will do.The Care Specialist works ... door knocks. Enroll patients into Upward Health's program and collect key data about patients during the enrollment process through continuous and on-going phone… more
