- Parexel (Trenton, NJ)
- …requirements. **Responsibilities** + Focus on exploratory work to generate evidence supporting clinical trial design, including outcome summaries and insights + ... outcomes. We are seeking a passionate and experienced **RWE** Specialist join our team and support the design and...data standards. + Good understanding of regulatory requirements & clinical trial design is preferred. **Why Parexel?**… more
- Parexel (Trenton, NJ)
- …work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected ... Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits,...stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial… more
- Parexel (Trenton, NJ)
- … clinical trials. Performs other duties as necessary to ensure optimal clinical trial execution. **Key Accountabilities** **:** **Study Team Support** + ... collection procedures and presentation slides) + Manages acquisition of clinical trial samples + Provides support for...study teams + Works with Informed Consent Form (ICF) Specialist and Precision Medicine Operations Lead (PMOL) to ensure… more
- Parexel (Trenton, NJ)
- …in Lupus is preferred -Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience The ability ... experience treating rheumatology patients clinically and/or who possess extensive rheumatology clinical trial related experience will be considered for this… more
- Sumitomo Pharma (Trenton, NJ)
- …on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring ... that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections....for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable… more
- Bristol Myers Squibb (Princeton, NJ)
- …effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ... adjusted when new or unanticipated issues arise once the trial has begun. **Key Responsibilities:** + Develop the Quality...with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections,… more
- Deloitte (Princeton, NJ)
- …clients within the Life Sciences & Healthcare sector, utilizing Veeva Vault Clinical Trial Management Systems (CTMS), Regulatory Information Management ( RIM) ... of health. Work you'll do As an Industry Solutions Specialist Leader you will lead the creation of innovative...Suite, and electronic Trial Master File (eTMF) + 6+ years of experience… more
- Norstella (Trenton, NJ)
- …& analytics **Requirements** + Deep knowledge and expertise of the pharma strategic Clinical trial landscape (Clin Dev/Ops, clinical development plan ... within Sponsor/CRO/Partner environment + Experience using data analytics and services to solve clinical trial challenges + Understanding of how, and where, AI… more
- Bausch + Lomb (Trenton, NJ)
- …ensuring alignment with global requirements. + Provide guidance on risk assessment, clinical trial design implications, and regulatory pathways. + Support ... regulatory strategies for development programs and marketed products across CMC and clinical /non- clinical , labeling, adpromo areas. Serve as a strategic advisor… more
- ThermoFisher Scientific (Lawrenceville, NJ)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- ThermoFisher Scientific (New Brunswick, NJ)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- Edwards Lifesciences (Trenton, NJ)
- …+ Nurse Practitioner or Physician Assistant in structural heart + Experience as a Clinical Specialist , Therapy Development Specialist , Clinical Education ... you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality… more
