- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in a medical device, pharmaceutical company, or similar environment (eg, CRO ) requiredExperience with clinical data standards requiredDaiichi ... outsourcing (eg, study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party vendors to ensure… 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)
- …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. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical ... External Data Management, is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company, or ... Management, is accountable for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical...similar environment (eg, CRO ); oncology, immunology, or complex disease required- 7+ years… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …with both Corporate and project goals.Building, managing, and maintaining high performing clinical teams.Provide input and leadership into CRO and vendor ... clinical trials report, investigator brochures, etc.) and trial conduct.Partner with Clinical Development, Data Sciences, Clinical Trial Supply… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key ... around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic… more
- Novo Nordisk Inc. (San Antonio, TX)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... employee in clinical , medical and/or regulatory in the pharmaceutical, biotechnology, CRO , and/or healthcare setting required A minimum of 2 years of direct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data , and collaborate with Imaging CRO on ... readers for assignment to similar studies/indicationsCross-Functional Collaboration: Collaborate with clinical team and/or statistical team to perform routine review… more
- Merck & Co. (Rahway, NJ)
- …support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and other ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management, and other ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and ... project management experiences are necessary.Solid knowledge of statistical analysis methodologies, clinical trial designs, and statistical and data processing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. ... all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead… more
- Merck & Co. (Rahway, NJ)
- …as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and ... expands the territory for clinical research, finding and developing new sites. Participates in...on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased.Subjects'… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outsourcing (eg, study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party vendors to ensure ... and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Integrated Resources, Inc (Smyrna, GA)
- …Reviewing study related documentation to ensure it is inspection ready. . Conduct Quality Control checks of the eTMF. . Support data integrity assessments. . ... Job Title: Clinical Development Quality Lead Job Location: Smyrna, GA...other health authority inspections of sponsor, investigator site(s), and/or CRO (s). . Self-motivated with the ability to take initiative,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position ... and global Health Authorities, as well as contract research organization ( CRO ) programmers and statisticians. Additionally, this position works under minimal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project needs. The position works closely with contract research organization ( CRO ) programmers and statisticians and collaborates with internal programmers in ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
