- Actalent (Pennington, NJ)
- …communication distribution, shipping, filing, tracking, and summarization. + Assist in the clinical trial insurance process by tracking approvals, revisions, and ... skills. Additional Skills & Qualifications + Minimum of an associate 's degree; bachelor's degree preferred. + Previous experience in... Trial Master File systems. + Experience in clinical trial management systems. Pay and Benefits… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments + Authors and/or reviews documents ... We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the… more
- IQVIA (Parsippany, NJ)
- …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 (Parsippany, NJ)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive,...required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- Merck (Rahway, NJ)
- …and Word **Preferred Experience and Skills:** + Strong preference for experience with clinical trial specialty services + Experience, either at a sponsor or ... **Job Description** The Associate Director is responsible for defining sourcing strategies... Director is responsible for defining sourcing strategies for Clinical Innovative and Decentralized Services in support of our… more
- J&J Family of Companies (Titusville, NJ)
- …to lead the development of data-driven digital products that accelerate and streamline clinical trial operations. This role will focus on designing and scaling ... development, site and country planning, and other high-impact areas of clinical trial productivity. As a hands-on product leader, you'll translate complex… more
- Merck (Rahway, NJ)
- …+ Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and...drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. +… more
- Merck (Rahway, NJ)
- …Engineering or related field plus 9 years SAS programming experience in a clinical trial environment. + MS in Computer Science, Statistics, Applied Mathematics, ... plus 7 or more years SAS programming experience in a clinical trial environment. **Department Required Skills and Experience:** + Excellent interpersonal skills… more
- Bristol Myers Squibb (Princeton, NJ)
- …aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape ... Professional (CMPP), and ISMPP active member highly desired + Understanding of clinical trial design and execution, statistical methods and clinical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … Director/Director). + An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and ... **Job Description** Otsuka is seeking a Director, Global Clinical Development (GCD), who will be responsible for the design and oversight of clinical research… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director, RBQM - HOCT, ICN will mainly be responsible for developing ... effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists with and may author/review ... process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical trial process improvements. Considerable organizational awareness, including… more
- Sumitomo Pharma (Trenton, NJ)
- …marketed products. + Conduct safety surveillance over product life cycle, reviewing clinical trial and post-marketing Individual Case Safety Reports (ICSRs), ... highly motivated, and experienced individual for the position of ** Associate Medical Director.** The Associate Medical Director...safety of clinical trials, including monitoring of clinical trial safety and laboratory data. +… more
- Hackensack Meridian Health (Hackensack, NJ)
- …works under the general supervision of the principal investigator responsible for the clinical trial (s) to which is assigned. **Education, Knowledge, Skills and ... Preferred:** + SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical … more
- Cytel (Trenton, NJ)
- **Who Are You?** An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you ... will support Phase I-IV clinical studies across your region. You are excited and...professionals responsible for supporting client's innovative science through novel trial design, data collection, integration, analysis, and enabling data-driven… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Statistical Project Leader **Location:** Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The ... teams accelerate progress. Join our **Biostatistics Immunology & Inflammation (I&I) as Associate Statistical Project Leader** and you will lead several I&I phase 2… more
- Bristol Myers Squibb (Princeton, NJ)
- …DSURs, etc. + Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments ... and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** The… more
- Bristol Myers Squibb (Princeton, NJ)
- …6 years of experience. Experience must include the following: + knowledge of clinical trial + postmarketing safety + marketing authorization filing and ... Lead Safety Data Review (SDR) Teams in the review and evaluation of clinical data to support signal detection. Specially, this position will perform the following… more
- Ascendis Pharma (Princeton, NJ)
- …tactics. + Interface with external experts (eg, key opinion leaders, clinical trial investigators, and other healthcare professionals) and internal ... for one or more rare disease therapeutic areas, the Associate Director of Global Scientific Publication Planning oversees the...stakeholders (eg, Clinical , Statistics, Medical Affairs,) to ensure publications address gaps… more
- Sumitomo Pharma (Trenton, NJ)
- …MHRA, and PMDA regulatory frameworks. + Proficient in end-to-end case management of clinical trial and post-market ICSRs. + Experienced in supporting partner ... a dynamic, highly motivated, and experienced individual for the position of ** Associate Manager, Compliance, Training & Strategic Alliance (CTSA), PVRM** . The … more