- Merck & Co. (Rahway, NJ)
- …The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). Contribute to the...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Merck & Co. (Rahway, NJ)
- …or related field plus 9-12 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... field plus 7 or more years SAS programming experience in a clinical trial environment.Required Experience and Skills:Excellent interpersonal skills and ability… 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
- Merck & Co. (Rahway, NJ)
- …or Master's plus minimum 7 years SAS programming experience in a clinical trial environmentExperience leading large and/or complex statistical programming ... Job DescriptionThe Associate Principal Programmer leads the statistical programming activities...to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data steps, procedures,… more
- Merck & Co. (Rahway, NJ)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Job DescriptionThe Associate Vice President (AVP) will be responsible for...strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the… more
- Merck & Co. (Rahway, NJ)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities in collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of clinical trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, IRBs, clinical research vendors). ... risk identification and mitigation planning for assigned clinical trial sites Drives and tracks site activation and start-up activities with clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities in collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics ... disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to 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
- 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
- ThermoFisher Scientific (New York, NY)
- … clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy ... Impactful Work:** Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts...study systems are updated per agreed study conventions (eg Clinical Trial Management System, CTMS). Performs QC… more
- Bristol Myers Squibb (Summit, NJ)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial ... team members + May support clinical development planning (collaboration with Clinical Development Lead/ Clinical Trial Physician for provision and… more
- System One (Plainsboro, NJ)
- Senior Clinical Research Associate - Regional Location: Home Based, Philadelphia, PA Area Type: Full time Start Date: ASAP Are you an experienced Clinical ... sites in a risk-based monitoring model. Responsibilities: + Responsible for providing site management and support to external trial staff (Principal… more
- Merck (Rahway, NJ)
- …The position will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively ... and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). + Contribute to...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… 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
- Hackensack Meridian Health (Hackensack, NJ)
- …change. The Clinical Research Nurse is responsible for coordinating and overseeing clinical operations of a clinical trial and participates in assessing, ... complete, up-to-date records on each patient participating in a clinical trial protocol in all applicable systems...Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified … more
