- 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
- 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)
- …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
- 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)
- … 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
- 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 (Rahway, 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the TMF technical capabilities and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program. The ... impact. Join Gilead and help create possible, together. **Job Description** The Associate Director, Clinical Records & Information Management will partner with… 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
- IQVIA (Parsippany, NJ)
- …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,...site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- Pfizer (Pearl River, NY)
- …plan. + Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy. + Ensure ... to enable quality, compliance and patient safety at the trial , site and patient level. + Ensures...+ Provides protocol specific training to study team, investigators, clinical research associate , and others. + Interacts… more
- Bristol Myers Squibb (Berkeley Heights, 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
- Bristol Myers Squibb (New York, NY)
- …and ethical standards + Ensures active participation of FM in providing input on clinical trial site selection and feasibility based on their knowledge ... of investigators in their geography + Ensures FM team's execution of clinical trial support activities (as per established study scope documents) + Ensures that… 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 (Rahway, NJ)
- …minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. + MS (preferred) in Computer Science, Statistics, ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. **Required Experience and Skills:** + Experience leading… more
