- 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
- 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
- Novo Nordisk Inc. (Atlanta, GA)
- …of clinical trials and 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. (North Wales, PA)
- …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... execution of 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
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills.… 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
- Merck & Co. (North Wales, PA)
- …of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in Computer Science, Statistics, Applied ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required Experience and Skills: Experience leading large… more
- Merck & Co. (North Wales, PA)
- …Operations Managers (CQOMs), GDMS, BARDS Statisticians and rest of members of the Clinical Trial Teams (including Country roles) to ensure that systems and ... (eg our company's IT data hub - InForm, DMW, Clinical Data Repository (CDR), Site Management Authoring... clinical quality framework.Profound knowledge and understanding of clinical development programs, clinical trial … more
- Merck & Co. (North Wales, PA)
- …Job Responsibilities Responsible for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team ... (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management… more
- Catalent (San Diego, CA)
- …and performance of line clearances in a Class 100,000 environment, maintenance of clinical trial material inventory logs;Duties include but not limited to ... Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… 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)
- …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. (Boston, MA)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational Medicine, will be responsible for leading the Translational… more
- Catalent (San Diego, CA)
- …performance of production audits in a Class 100,000 environment, maintenance of clinical trial material inventory logs.Other duties as assignedThe Candidate: ... Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Merck & Co. (North Wales, PA)
- …or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Merck & Co. (North Wales, PA)
- …support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the ... in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… 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
