- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s),...communicate materials, in support of the PSL. Independently evaluates safety data of any source to identify… more
- Novo Nordisk Inc. (WA)
- …the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory and ... Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials Verifies safety reporting and the...relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ... process solution, and customer experience Querying and ReportsDevelop complex ad hoc safety database searches and report output.For all data requests, perform… more
- Merck & Co. (Rahway, NJ)
- …including complex data preprocessing, filtering, and manipulation;Programming expertise with clinical endpoint data (efficacy and safety ) and ... and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the … more
- Merck & Co. (North Wales, PA)
- …and high-quality data to support decision making in clinical trials.-The Associate Principal Scientist, Statistical Programmer supports the ... global human health. Our Quantitative Sciences team uses big data to analyze the safety and efficacy...Specific Required Skills and Experience:Significant expertise in SAS and clinical trial programming including data steps, procedures,… more
- Genmab (Plainsboro, NJ)
- …as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Genmab (Plainsboro, NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- ... management of Senior Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/ Associate... committees Participate as a member of the first safety committee chaired by non- clinical , where … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Associate (1st and 2nd shift openings available) as part of the Technical ... operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Eisai, Inc (Louisville, KY)
- …on utilization of promoted Oncology therapeutic products for specific indications; deliver clinical , efficacy, and safety messaging to target physicians in a ... Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with… more
- Eisai, Inc (San Francisco, CA)
- …on utilization of promoted Oncology therapeutic products for specific indications; deliver clinical , efficacy, and safety messaging to target physicians in a ... Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with… more
- Pfizer (South San Francisco, CA)
- …You Will Achieve** It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an ... **Power Your Purpose** Pfizer Worldwide Medical and Safety colleagues play a key role in connecting...important role in processing, reviewing and receiving clinical data and records and from therapeutic… more
- Cedars-Sinai (Beverly Hills, CA)
- …required. Bachelor's Degree preferred. \#Jobs-Indeed **Req ID** : 3700 **Working Title** : Clinical Research Data Associate I (Hybrid) **Department** : ... **Job Description** Primary Duties and Responsibilities The Clinical Research Associate I works directly...research objectives. Responsible for completing case report forms, entering clinical research data , and assist with regulatory… more
- ThermoFisher Scientific (Cambridge, MA)
- …Specific Information \#CorEvitas Discover Impactful Work: As part of the Clinical Data Management (CDM) team, the Associate Director of Clinical ... High school diploma required. Experience * 7 or more years' experience within Clinical Data Management in biopharmaceutical/biotech, or CRO setting. * 3 or… more
- Pfizer (Groton, CT)
- …You Will Achieve** It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an ... **Why Patients Need You** Pfizer Worldwide Medical and Safety colleagues play a key role in connecting...important role in processing, reviewing and receiving clinical data and records and from therapeutic… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s),...communicate materials, in support of the PSL. Independently evaluates safety data of any source to identify… more
- Penn Medicine (Philadelphia, PA)
- …+ Ensures safety , confidentiality & security of employee and Patient data . + Assists/Trains internal team members, physicians, clinical and practice staff ... a Bachelor's degree, and at least 2 years of related experience are encouraged to apply! Associate Clinical Analyst: + An Associate Clinical Analyst may… more
- Mount Sinai Health System (New York, NY)
- …Pro) are desirable. **Responsibilities** ** Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB):** + Synthesizes information from various ... team and monitors all safety aspects of clinical research trial(s). Under guidance of the Associate...+ Monitors timelines for adverse event processing, reviews summary safety data at regular intervals and monitors… more
