- Merck & Co. (Rahway, NJ)
- …costs, executing contracts and ongoing contract management. This role will report to the Associate Director, Clinical Trial Central Labs to support high ... influence stakeholders and suppliers in the context of a challenging clinical trial environment.Must be adaptable in dealing with ambiguous and complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM).ResponsibilitiesLead the authoring, revising, and managing ... authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will… more
- Daiichi Sankyo, Inc. (Bernards, 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)
- …or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... related field plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and laboratory data expertise to promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to ensure all laboratory data ... similar environment (eg, CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management. required- 4+… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Merck & Co. (Rahway, NJ)
- …the Immunology TAWork closely with a cross-functional group of experts, including clinical directors, clinical trial operations, and biomarker operations ... Clinical Immunology, Clinical Medicine, Clinical Research, Clinical Testing, Clinical Trial Management, Cross-Cultural Awareness, Cross-Functional… more
- Mount Sinai Health System (New York, NY)
- …Experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is highly desirable. **Responsibilities** ... Research Associate I monitors all aspects of clinical research trial (s) Clinical study... trial (s) and investigative sites and maintenance of clinical trial master file (CTMF): assures all… more
- Merck (Rahway, NJ)
- …costs, executing contracts and ongoing contract management. This role will report to the Associate Director, Clinical Trial Central Labs to support high ... support for Clinical Development Sourcing and Procurement (CDSP) in Clinical Trial Central Labs. This includes sourcing of clinical services utilizing… more
- Actalent (Parsippany Troy Hills, NJ)
- …creation, and ensure compliance with quality measures and timelines. + Monitor clinical trial performance and quality metrics, escalating issues and proposing ... and provide expert-level guidance. The position reports to an Associate Director and involves both strategic planning and operational...Qualifications + 7+ years of experience as a GLOBAL Clinical Trial Manager with a pharmaceutical or… more
- IQVIA (Parsippany, NJ)
- …is required, Nursing experience in addition to this is ideal!_ **Job Overview** Associate Clinical Project Managers (aCPM)/Local Trial Managers are an ... integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The aCPM is a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... + Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates management… more
- Actalent (Basking Ridge, NJ)
- …agreed budget against trial progress. Essential Skills + 7+ years of clinical trial management experience. + Experience with global study management (Any ... Job Title: Associate Director Clinical Operations Job Description Align with the Head of Clinical Development Operations or Senior Director, Clinical … more
- IQVIA (Parsippany, NJ)
- …applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. ... with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. *… more
- IQVIA (Parsippany, NJ)
- …applicable, 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,...required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's… more
- J&J Family of Companies (Raritan, NJ)
- …more at https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Support **Job Category:** Professional **All Job Posting ... trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …& Logistics (SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM). **Responsibilities** + Lead the authoring, revising, ... authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will… more
