- Novo Nordisk Inc. (Plainsboro, NJ)
- …of clinical trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that ... US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance...projects for NACD & Novo Nordisk (eg Investigators and site staff, vendors etc.). Establish and manage senior level… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …business, and other functional groups across NN. External relationships can include clinical trial sites and external vendors. Essential Functions Develop and ... escalating quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP...or resolve, for example across various topics, such as clinical trial management, deviation handling, and product… more
- Insmed Incorporated (Bridgewater, NJ)
- …and collecting TMF status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and ... in the review, processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of work and contract terms.Assists… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) and/or ... of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Insmed Incorporated (Bridgewater, NJ)
- … Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the protocol ... section development, study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams.ResponsibilitiesAdditional representative responsibilities… more
- Bausch Health (Bridgewater, NJ)
- … Trial Master File structure and preparation, and communication with clinical trial sites regarding administrative documentation, support materials and ... studies + Supports CTM and clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logistical management of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the Clinical Study Lead (CSL) by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies ... a hybrid position which means the individual must work on- site 3 days per week. Fully remote work is...maintenance of study systems including but not limited to Clinical Trial + Management System (CTMS) and… more
- Actalent (Basking Ridge, NJ)
- …from monitoring plan + Monitors and updates investigator/ site status for the trial , and supports with clinical trial registry postings + Contributes ... Immediate Opening for Clinical Trials Assistant/ Associate Description: + ...+ Collates data for assessments such as feasibility and site selection and reviews site usability database… more
- Kelly Services (New York, NY)
- …aspects of a clinical trial including, but not limited to, clinical site selection, study visits, preparation of study contracts and budgets, and ... clinical study, including (but not limited to): + Clinical site selection + Site ...plan, case report forms, etc.). + Remain current on clinical trial regulatory requirements and guidelines (eg… more
- Merck (Trenton, NJ)
- **Job Description** **Position Description:** ** Associate Clinical Research Manager (aCRM) - Oncology** With support of other Clinical Research Manager's ... Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). + Responsible for project management of the… more
- Merck (Trenton, NJ)
- …The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed ... Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT). + Collectively and...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- WuXi AppTec (Cranbury, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... clinical monitoring and required reporting, including pre-study visits, site invitation visits, routine monitoring visits (both onsite and...or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II… more
- Merck (Rahway, NJ)
- …members including clinical directors and study managers to lead/support clinical trial scientific activities. **Job Responsibilities** + Responsible for the ... clinical protocol(s). + Serves as the lead clinical scientist on the clinical trial...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Bristol Myers Squibb (Trenton, NJ)
- …and ethical standards + Ensures active participation of FM in providing input on clinical trial site selection and feasibility based on their knowledge ... then mobilizing them to respond to customer needs **_Clinical Trial / Site Identification & Support_** + Tracks FM...Identification & Support_** + Tracks FM region activity toward clinical trial visits/ISR management, as appropriate +… more
- Bristol Myers Squibb (Princeton, NJ)
- …drives the development and implementation of innovative strategies and technologies for clinical trial programming. Associate Director develop collaborative ... the development and implementation of innovative strategies and technologies for clinical trial programming + Independently develops, validates, troubleshoots,… more
- Bristol Myers Squibb (Princeton, NJ)
- …the development and implementation of innovative strategies and technologies for clinical trial programming. A ssociate Director develop collaborative ... the development and implementation of innovative strategies and technologies for clinical trial programming + Independently develops, validates, troubleshoots,… more