- Merck & Co. (Rahway, NJ)
- … supply chain across the full Company's Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… more
- Merck & Co. (North Wales, PA)
- …Documentation, Clinical Investigations, Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation, Clinical ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical...of assets within the pediatric section of the Vaccine Clinical Development TA.May serve as a senior … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready...and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel:… more
- Merck & Co. (North Wales, PA)
- …decision-making skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in ... including regulatory submissionsDemonstrated history of development and execution of innovative clinical trial designs and exploration of novel analysis methods… more
- Nurix (San Francisco, CA)
- …chapter with a new script to outmatch disease. Responsibilities and Duties: The Senior Manager/ Associate Director of Clinical Quality Assurance Auditor is ... Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, Clinical Trial Sites and laboratories. This role may have future… more
- DermBiont (Emeryville, CA)
- …in support of preclinical studies and clinical trials. Audit and review clinical trial documents, reconcile audit results from multiple sources, and maintain ... Organization: DermBiont is a clinical stage biotech company with multiple active INDs...all regulatory requirements. This position will report to the Senior VP of Development. Qualifications: Have at minimum a… more
- Bristol Myers Squibb (Princeton, NJ)
- …decision-making throughout execution. You will apply a strong foundation in both clinical trial science and applied analytics - from understanding protocol ... . **Position Summary** The TAIP Principal Analyst is a mid- senior level role within Bristol Myers Squibb's Trial...trial strategy is required + Prior exposure to clinical trial delivery processes and data-driven decision… more
- J&J Family of Companies (Jacksonville, FL)
- …are searching for the best talent to join our Vision team as a **Staff Clinical Trial Specialist** located in **Jacksonville, FL or Irvine, CA.** Fueled by ... operating procedures and company policies are followed. The Staff Clinical Trial Specialist develops and manages timelines,...have a minimum of 2 years' experience as a clinical research associate + Complete understanding and… more
- Avania (OR)
- Avania are hiring for the key role of experienced Clinical Research Associate (CRA) or Senior Clinical Research Associate (Sr CRA) As a CRA/Sr CRA ... for several studies running in parallel, in all associated clinical trial phases, from regulatory submissions to...3 + years of relevant work experience as a clinical research associate - CRA. + Attention… more
- United Therapeutics (Research Triangle Park, NC)
- …disease process, and lead protocol development and writing. **Minimum Requirements** + For Senior Clinical Drug Development Scientist level: + 10+ years of ... + Demonstrated understanding of the overall drug development process with clinical trial design, study implementation, sponsor/site interactions, external… more
- BeOne Medicines (Emeryville, CA)
- …with CRAs to ensure data collection is met per contractual guidelines * Works with Clinical Trial Oversight Managers (CTOMs) and Clinical Study Team (CST) to ... Familiar with industry CTMS and data management systems **Other Qualifications:** * Understands clinical trial processes with a thorough knowledge of ICH and… more
- IQVIA (Carlsbad, CA)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. *… more
- IQVIA (Carlsbad, CA)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... IQVIA Biotech is hiring for our Early Clinical Development team. Ideal candidates will have Phase...required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- J&J Family of Companies (Cambridge, MA)
- …disease area and/or pathway strategies. They will be empowered to lead a cross-functional clinical trial team to deliver on the trial 's major execution ... We are searching for the best talent for an Associate Director, Translational Medicine Clinical Lead, Translational...study of immunologic disease, immunologic pathways, and in early clinical trial design and execution. TS has… more
- Abbott (Abbott Park, IL)
- …and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Senior Clinical Site Lead** Summary The Senior Clinical ... (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and ...competent authority/ethics committee. Beyond developing and maintaining a productive clinical territory, the Senior Clinical … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and/or late phase development. The Senior Manager reports to the Associate Director, Clinical Sciences and collaborates closely with Medical Director(s) ... The Senior Manager, Oncology, Clinical Scientist leads...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- Abbott (Minneapolis, MN)
- …Summary Under the supervision of senior colleague/manager (or delegate), the Associate Clinical Site Lead drives study execution and operational excellence ... (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and ...a level that allows for appropriate collaboration with Abbott clinical staff, eg Site CRA, Site Contract Associate… more
- Amgen (Washington, DC)
- …the use of data to advise program and study design, including: patient-level historical clinical trial data (HTD), real world data (RWD) assets, and other data ... and 8 years of research design experience Or + Associate 's degree and 10 years of research design experience...them (fit for purpose approach); including Real World Data; clinical trial data; + Ability to integrate… more
