- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Sr. Investigator as part of the Technical Operations team based in Raritan, NJ.Role ... OverviewThe CAR-T Sr. Investigator will be part of the Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator -sponsored studies (ISS) and provide comments to RGC Chair Attend ... in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with… more
- NYU Langone Health (New York, NY)
- …Diabetes & Metabolism at NYU Langone Health invites applications for a Clinician- Investigator with demonstrated expertise in clinical trials focused on diabetes and ... an academically oriented physician with a track record of leading investigator -initiated and/or industry-sponsored clinical trials, and the ability to manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Inform Finance of deviations-Review and approve Vendor invoices, including investigator grants and pass through costs. Quality and inspection readiness:Support ... inspection readiness and quality initiatives pertaining to assigned study(ies).Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key ... thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations.Works with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other cross-functional and regional stakeholders.Provides support in review of investigator -initiated studies (IIS) and may serve as deputy compound lead in ... Global IIS Review Committee meetings.Leads external medical education and other scientific exchange activities in alignment with the Senior Director, such as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates… more
- HSBC (New York, NY)
- Investigator FC Investigative Reporting Brand: HSBC Area of Interest: Risk and Compliance Location: New York, NY, US, 10001 Work style: Hybrid Worker Date: 15 Dec ... in order to determine if the filing of a SAR is required. As our Investigator FC Investigative Reporting, you will: - Reviews and evaluates cases referred from the… more
- Formation Bio (New York, NY)
- …Support protocol development and development of essential documents (eg, Investigator 's Brochures, informed consent forms) by providing critical operational ... insights. Remain current on emerging industry trends, regulatory updates, and best practices, pivoting operational strategies to maintain competitive advantage. AI and Technology Enablement Leverage AI-powered tools and technology platforms to streamline… more
- Formation Bio (New York, NY)
- …Oversee GXP, Data Integrity, and CSV activities across various entities, investigator sites, research organizations, clinical and nonclinical studies, PV vendors, ... and CDMOs. Maintain efficient systems and processes that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards. Provide leadership and direction to the quality assurance team, ensuring that all quality activities are… more
- Parexel (Trenton, NJ)
- …the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance ... The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (eg… more
- Parexel (Trenton, NJ)
- …the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance ... The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (eg… more
- Parexel (Trenton, NJ)
- …scientific questions, provide daily medical support to Parexel staff or site ( investigator /study coordinator), as needed + Review and sign off adverse events report ... as requested, at internal and external meetings (such as investigator meetings) + Provide medical safety expertise to client...follow up as appropriate with the project team, sponsor, investigator , and Regulatory Authorities + Review and sign off… more
- Parexel (Trenton, NJ)
- …in the delivery of monitoring + Supports the CRA to develop positive Investigator relationships throughout the life of the study and escalate any training or ... new processes and systems + Identifies and builds effective relationships with investigator site staff and other stakeholders + Effective verbal and written… more
- Parexel (Trenton, NJ)
- …data from study sites as per required timelines. + Manages study supplies ( Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. ... visit reports in CTMS and provides timely feedback to the Principal Investigator , including follow-up letter, within required timelines and in line with Client… more
- Parexel (Trenton, NJ)
- …data from study sites as per required timelines. + Manages study supplies ( Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. ... visit reports in CTMS and provides timely feedback to the Principal Investigator , including follow-up letter, within required timelines and in line with Client… more
- Parexel (Trenton, NJ)
- …with feasibility leaders, solution consultants + Participate in team project and investigator meetings + Provide training of study teams on TA indication and ... preferred -Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience The ability to travel 15-20% is… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …with practical deployment in healthcare systems. **Additional Information:** + Reporting to Physician Investigator , SKI + Schedule: 9:00 AM - 5:00 PM EST, Monday - ... Friday + Location: Hybrid; 99% remote with ability to come on site 1-2 times a year **Helpful Links:** Compensation Philosophy (https://careers.mskcc.org/frequently-asked-questions/) Benefits Pay Range: $148,100.00 - $244,400.00 FSLA Status: Exempt **Closing**… more
- Parexel (Trenton, NJ)
- …to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final ... clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …and retain outstanding faculty; build high-performing, inclusive teams; and grow multi- investigator research programs. + Track record of methodologic innovation and ... impactful scholarship; success securing federal, foundation, and/or industry funding. + Exceptional communication, collaboration, and stakeholder engagement skills; highest standards of professional ethics and integrity. **Core Skills:** + Strategic planning… more
- Parexel (Trenton, NJ)
- …+ Experience as a Physician in Industry or as a clinical trial investigator is required + Previous CRO experience is strongly preferred + Medically qualified ... in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship) The ability to travel 15% domestically or internationally is required \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity… more
