- Bayer (Whippany, NJ)
- …the creation of clinical documents or components of key documents (eg, Clinical Study Protocol, Investigator Brochure, Clinical Study Report, regulatory ... teams, collaborating across the organization and externally with service providers and investigator sites;Review clinical trial data both internally and from… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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 ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Eisai, Inc (Nutley, NJ)
- …Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for communication between Eisai ... Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as a conduit for communication between Eisai… more
- Eisai, Inc (Nutley, NJ)
- …looking for a scientifically driven imaging expert with deep knowledge of Oncology clinical trials to shape the future of imaging science across its development ... imaging acquisition strategies, biomarkers, and advanced analytics to support translational and clinical goals. At the same time, they will ensure data quality,… more
- MVP Health Care (Tarrytown, NY)
- …innovative thinking and continuous improvement. To achieve this, we're looking for a ** Clinical Investigator ** to join #TeamMVP. This is the opportunity for you ... investigation experience involving economic or insurance related matters. + A clinical investigator must have in addition to the above requirements: A duly… more
- Mount Sinai Health System (New York, NY)
- …The **Project Manager II** will oversee the entire portfolio of Investigator -Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor Collaboration ... in clinical research, including at least 2 years managing investigator -initiated trials preferred. + Proven track record in regulatory compliance, project… more
- Sanofi Group (Morristown, NJ)
- …requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA...turn the impossible into possible for millions. The Senior Clinical Research Director (CRD) is an **expert clinical… more
- Mount Sinai Health System (New York, NY)
- …clinical trials. + Obtains informed consent under supervision of the Principal Investigator , Clinical Research Manager, or Senior Clinical Research ... education, and innovative community based programs. Under minimal supervision, the Clinical Research Coordinator II coordinates the clinical assessments of… more
- Mount Sinai Health System (New York, NY)
- …and family members who have concerns and escalates to Principal Investigator /Sub- Investigator , Clinical Nurse Manager/Assistant Nurse Manager/Nursing Shift ... **Job Description** The Clinical Research Nurse is a Registered Professional Nurse...and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges.… more
- Organon & Co. (Jersey City, NJ)
- …medicine and clinical pharmacology components of TMED study protocols, clinical study reports, Investigator Brochures, briefing books, IND subsections, ... translational medicine and clinical pharmacology components of study protocols, clinical study reports, Investigator Brochures, briefing books and other… more
- Bayer (Whippany, NJ)
- …the creation of clinical documents or components of key documents (eg, Clinical Study Protocol, Investigator Brochure, Clinical Study Report, regulatory ... across the organization and externally with service providers and investigator sites; + Review clinical trial data...service providers and investigator sites; + Review clinical trial data both internally and from external vendors/partners,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …adverse events (SAEs), and emerging safety signals. + Review documents supporting clinical development such as Investigator 's brochure, regulatory documents for ... Clinical Study Physician Date: Dec 3, 2025 Location:...and interim cuts. Supports site selection, patient recruitment, and investigator engagement through regular interactions and guidance. + Leads… more
- Mount Sinai Health System (New York, NY)
- …in clinical research studies under the supervision of the Principal Investigator or senior clinical research staff. This individual obtains informed consent, ... matter of the research project, under direct supervision of the Principal Investigator or senior clinical research staff. + Assists in the activities related to … more
- Pfizer (New York, NY)
- …documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, ... relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and… more
- Sanofi Group (Morristown, NJ)
- …docs and supports registration, labelling etc + Develop and/or contribute in the clinical section of the Investigator 's brochure, CTA, IND, DSUR, DRMP, RMP ... **Job Title:** Senior Clinical Research Director **Location:** Cambridge, MA or Morristown,...the elaboration of training material and presentations at the investigator meetings/local teams trainings + Answer to medical questions… more
- AbbVie (Florham Park, NJ)
- …design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and ... Description With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development… more
- IQVIA (Parsippany, NJ)
- …sponsor point of contact, global cross functional business partners + **Others:** Clinical Investigator Sites, Commercial Suppliers, Clinical Trial Insurance ... Overview** Join a team that's shaping the future of clinical research! We are seeking a **Global Program Analyst**...Program Analyst** to support critical services that enable successful clinical trials worldwide. In this role, you will manage… more
- Mount Sinai Health System (New York, NY)
- …of hematology/oncology Principal Investigators and researchers with development of investigator -initiated clinical trial protocols. Must understand complex ... obtains approval from the Food and Drug Administration (FDA) for investigator -initiated clinical trials. Acts as primary contact for all FDA communication,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …documents (DSURs, PSURs, development RMPs, RMPs, etc.) and the review of clinical documents ( Investigator Brochures, protocols, clinical study reports, ... drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS;… more
