- Genmab (NJ)
- …Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely ... excellence.Responsibilities:Contributes to and implements the strategic direction of the Clinical Data Management functional areaContributes to the overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... and collaborates as team member with other functions, ARO, CRO . Provides scientific input to Clinical Operations...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Contract Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all programming ... data review listings and reports to support Data Management and clinical teams. Develop, implement...5 years (w/BS) or 4 years (MS) SAS and clinical programming experience in the biotech/pharmaceutical/ CRO industry… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Certified MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience in a medical device, ... pharmaceutical company, or similar environment (eg, CRO ) requiredOncology, immunology, or complex disease clinical ...MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding… more
- Genmab (NJ)
- …implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various ... stages of clinical development (including clinical trial implementation, and...completion guidelines, and provide scientific support for other key data management deliverables (eg database lock activities). Lead the… more
- Genmab (Plainsboro, NJ)
- …5+ years in clinical operationsSignificant experience leading clinical projectsExperience managing/guiding internal (cross-functional) and external ( CRO , ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development Strategy: Provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical , medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/ CRO ) A minimum of 7 years supervisory experience required Experience leading ... 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
- Genmab (Plainsboro, NJ)
- …regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for ... if applicable Collaborate with the Labeling Team Lead to develop Company Core Data Sheet and US Prescribing Information depending on the role for the assigned… more
- BioAgilytix (Durham, NC)
- …and qPCR techniques with the ability to perform assays independently in a CRO /CDMO environment. In this dynamic role, you will thrive in a milestone-driven ... environment, actively contributing to data generation while providing scientific input.As a Scientist I,...quantitation of specific nucleic acids for CMC, preclinical and clinical studies supporting the pharmaceutical development of cellular and… more
- Takeda Pharmaceuticals (Columbus, OH)
- …across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for ... knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely...degree of quality. + Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. + Provides… more
- United Therapeutics (Research Triangle Park, NC)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Clinical Data Management Programmer is responsible for both programming and ... clinical trials at a pharmaceutical, medical device or CRO company + 2+ years of SAS programming experience...Trials Programming Using SAS 9.4 and + SCDM Certified Clinical Data Manager or Certified Clinical… more
- J&J Family of Companies (Raritan, NJ)
- …Research Organization ( CRO ), or related industry is required. + Clinical data management experience and/or knowledge of scientific concepts presented ... Johnson & Johnson is currently seeking an Analyst II, Clinical Data Manager. This position can be located in Raritan, NJ; Titusville, NJ; or Spring House, PA.… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12521BR** **Title:** Sr. Manager, Clinical Data Management **Job Description:** The Senior Manager, CDM oversees clinical data management activities ... management processes to ensure complete, accurate, high quality clinical data and adhering to Good ...data - management experience in the pharmaceutical, device or CRO setting. 3. Previous supervisory experience. 4. Proven ability… more
- Pfizer (Groton, CT)
- …improving patients' lives by ensuring the accuracy, timeliness, and consistency of clinical data . Your work will bridge evidence-based medical decision support ... and receive patient data and records, ensuring accurate, timely, and consistent clinical data reaches the medical department and other groups. + Develop … more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. Senior Manager - Clinical Data Management **What you will do** Let's do this. Let's change ... **Basic Qualifications:** + Doctorate degree and 2 years of clinical data experience OR + Master's degree...organization + Previous experience at or oversight of outside clinical research vendors ( CRO 's, central labs, imaging… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... and collaborates as team member with other functions, ARO, CRO . Provides scientific input to Clinical Operations...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Contract Research Organization ( CRO ) Medical Monitor (MM): + Provides oversight to the CRO MM for clinical data review activities + May support ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review + Conducts clinical data review per Integrated Data Review Plan (IDRP) + Accountable… more
