- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has ... medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal… more
- Merck & Co. (Rahway, NJ)
- …situations of low or non-performance.The role will work across the different country operations roles (eg CRM( Clinical Research Manager ), CRA( Clinical ... Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role...the CTCs, as well as for interns-delegated to the Clinical Operations team based on the Internship… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference ... (eg, Executive Committee). Provides input to Clinical Operations on monitoring plan (eg data fields to be SDV'd) and to Biostatistics on Statistical… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our… more
- Merck & Co. (North Wales, PA)
- …database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager ...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, taking responsibility of ... continuity of site relationships through all-phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,-Sponsor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing data collection, data ... optimal approaches to support the collection of diverse external data types.Advises Study Data Manager ...is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… 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, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… 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 ,...including data standardization, natural language processing o Data Quality operations that standardize data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver upon near ... clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical ...compliance with standard processes, policies and procedures Collaborates with Clinical Finance & Operations to ensure the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) for establishing data collection, ... meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when...standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Drug Product QC Testing, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Key ... the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed… 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), ... one or more key functions (eg, clinical research, clinical operations , data management, biostatistics, project management) required- Collaboration,… more
- Aequor (NJ)
- …and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners. Collaborating with Global Clinical ... 100 % remote Manager prefers local candidates (will consider non local...CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, ... 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… more
- Aequor (New York, NY)
- …Management and COHN-S certificationsMajor Responsibilities: Assist in coordination of clinical operations , including medical surveillance, OSHA recordkeeping, ... Job Description: Position Purpose:Provide clinical services to employees within regulated scope of...site health promotion and disease prevention programs Documents patient data in electronic medical database(s), as per standard protocols… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
