- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Job DescriptionDirector, Clinical Research ScientistServe as a key role in contributing to the scientific and ... expertise in a therapeutic area leading one or more clinical trials for one or more compounds in various...(eg database lock activities)Lead the development of the medical data review plan (MDRP), perform ongoing data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The Programming Manager, Clinical Programming is responsible for ensuring integrity, consistency and adherence to Study ... Data Tabulation Model (SDTM) standards, perform sponsor oversight of...This role reports to the Director, Team Lead of Clinical Programming.Responsibilities/tasks - including but not limited to:Implements and… more
- Formation Bio (New York, NY)
- …drivers. Facilitate effective communication and collaboration between internal teams, such as Clinical Development, Clinical Data Management, and Site ... and comply with regulations. Capabilities to include the operational aspects of clinical trials, including protocol development, site selection, data collection,… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SAs) or Senior SAs who assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices (GCPs), appropriate ... guidelines. The SA Manager will ensure the SAs provide clinical administrative support to the study teams and support...to the study teams and support interactions with the Contract Research Organizations (CROs) and other vendors conducting the… more
- Genmab (NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... us!The Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early… more
- Genmab (NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of… more
- Genmab (NJ)
- …scope. The Programming Manager will work with other functions including Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology,Translational ... and ADaM database standards. Supports specification and pooling of data across clinical trials within the same...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems/capabilities with the R&D functional area, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug ... CROs/vendors, QA, and IT. This position may require line management responsibility of data maintenance specialists, who are primarily responsibility for the data … more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …using suitable Pharmacovigilance database retrieval strategies. Experience with safety data collection and interpretation originating from clinical trials ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...concerning safety promotional review, safety labelling committee input, safety data analysis and contract review and vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position ... global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works… more
- Merck & Co. (Flagstaff, AZ)
- Job DescriptionThe-Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education and ... to support customer operational and financial needs such as reimbursement information and contract adherence in an effort to help the provider or system increase… more
- Merck & Co. (Rahway, NJ)
- …processing. -Technical ScopeParticipates in teams focusing on late stage clinical process development, characterization, and technology transfer and validation with ... either in-house or externally.-Provides technical leadership for the design of experiments, data analysis and interpretation, as well as the execution of (internal)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Merck & Co. (Rahway, NJ)
- …in and/or leads cross-divisional technical teams focusing on late-stage clinical process development, characterization, and/or technology transfer and validation ... in-house or externally.- Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior staff in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be ... executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance… more
- Astellas Pharma (Northbrook, IL)
- …sites and others as needed to facilitate master clinical trial agreements/ clinical trial agreements ensuring that contract language provided to clinical ... and Scope:** This position will work within the Site Contract & Budget function reporting to the Regional Site...relates to applying the relevant legal requirements and global data privacy matters in the support of clinical… more
- Magellan Health Services (Covington, KY)
- …and consistent in accomplishing expected objectives. General Job Information Title Licensed Clinical Counselors, EAP - Federal Contract - ONSITE in Covington, ... This position is contingent on a contract award. Provides direct support to organizations and...organizations on variety of workplace and work-based issues. Provides clinical expertise in order to restore employees with diminished… more
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