- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the study; Identify issues and propose solutions.Responsible for ensuring that the Clinical CRO (s) provide timely input and generate documents in a timely ... device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization ( CRO ). CRA experience is preferred. Clinical Project Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Metrics and Analytics:Ability to analyze data/metrics/key performance indicators to support vendor/ CRO oversight of CRAs in clinical trials.Contribute to ... Monitoring Oversight and Excellence and the CSOP as it relates to monitoring and CRO /vendor oversight. This is a highly collaborative and dynamic role within a fast… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to...KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility ... Director, Clinical Development Join a Legacy of Innovation 125...of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and… more
- Genmab (NJ)
- …Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely ... delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide...Genmab SOP/processes and standards and ICH-GCPProvides oversight of DM CRO including Statement of Work, budget, KPIs, and performs… 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)
- …with some supervision. This position also guides contract research organization ( CRO ) programmers and statisticians in preparing analysis files and performing ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… 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 ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO /vendor proposal and budget.… 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...study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... for the financial management and budget development of North America Clinical Operations (NACO). Responsible for driving financial oversight across trial portfolios… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a medical device, pharmaceutical company, or similar environment (eg, CRO ) requiredOncology, immunology, or complex disease clinical trial experience ... of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QualificationsMinimum of 5 years (w/BS) or 4 years (MS) SAS and clinical programming experience in the biotech/pharmaceutical/ CRO industry required Daiichi ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within ... departments within the Company. Also communicates with outside consultants (ie CRO 's) as needed. Qualifications: Successful candidates will be able to meet… more
- J&J Family of Companies (Titusville, NJ)
- Johnson & Johnson is recruiting for a Manager, Functional CRO Category, within our Innovative Medicine R&D Procurement team. The position may be located in ... insights and innovation to the Johnson & Johnson Innovative Medicine Clinical Development organization? Key Responsibilities: + Understand the Innovative Medicine… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …the study; Identify issues and propose solutions. + Responsible for ensuring that the Clinical CRO (s) provide timely input and generate documents in a timely ... device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization ( CRO ). CRA experience is preferred. Clinical Project Management… more
- Actalent (Philadelphia, PA)
- Job Title: Lead Clinical Study Manager Job Description The Lead Clinical Study Manager will be responsible for ensuring the delivery and execution of clinical ... one or more geographic regions. This role requires adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directive,… more
- Dignity Health (Phoenix, AZ)
- …in Contract Research Organization ( CRO ) activities as well as the conduct of clinical trials at a site level. A unique skill-set with high attention to detail ... we are proud_ _to be_ _a tobacco-free campus._ **Responsibilities** The Clinical Research Regulatory Project Manager position exists to support research divisions… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Principal Scientist I, Non- Clinical Study Manager **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The ... skills could be critical in helping our teams accelerate progress. The Non- Clinical Study Manager (NCSM) will manage the outsourcing operations for preclinical… more
- Takeda Pharmaceuticals (Columbus, OH)
- …company to inspire you and empower you to shine? Join us as a Clinical Operations Manager based remotely reporting to the Clinical Operations Leadership team. ... **_GOALS:_** Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical… more
- Fresenius Medical Center (Baton Rouge, LA)
- …research organization ( CRO ) by monitoring and tracking the progress of clinical study activity at research sites. Provides support with regulatory agency and ... inspections/audits as needed. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Manage clinical research staff including but not limited to: interviewing potential… more
