- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs ... . - Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at… more
- Merck & Co. (North Wales, PA)
- …Responsible for leading specific aspects of clinical/scientific execution of clinical protocol (s). This may include:Serving as the lead clinical scientist on the ... monitoring team in review and interpretation -of clinical data/medical protocol deviations in collaborations with the Clinical Director.Other responsibilities… more
- Merck & Co. (North Wales, PA)
- …for leading specific aspects of clinical/scientific execution of clinical protocol (s). This may include:Serving as the lead clinical scientist on ... monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.Other responsibilities… more
- Genmab (NJ)
- …member:Participate and represent BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable ... SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.Review assay… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher ... quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Genmab (NJ)
- …applicableCTT member:Participate and represent BiostatisticsReview and provide input to protocol and amendment development Perform vendor oversight according to ... applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEsBiomarker strategies towards patient selection, patient ... of samples from clinical trial and screen failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device… more
- Merck & Co. (San Antonio, TX)
- …to patient enrollment and retention efforts to achieve study milestones. Protocol lead responsibilities in collaboration with Global Clinical Trial ... OperationsAddresses questions from investigators and provides information regarding participation in Company-sponsored clinical studiesScientific Congress SupportEngages in scientific congresses and medical meetings, facilitates scientific and data exchange… more
- Merck & Co. (Rahway, NJ)
- …in endeavors ranging from drafting clinical study protocols to overseeing protocol adherence to assessing patient-level data, ensuring data completeness and ... integrity, and ultimately interpreting and contextualizing aggregate data to assess safety and efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (North Wales, PA)
- …and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate.May serve as a subject matter expert ... and/or participate on process improvement teams . Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities.May include management of direct/ indirect reports including assignment of resources,… more
- Merck & Co. (Durham, NC)
- …diagnostic tools (such as meters, HART communicators and Foundation Fieldbus protocol devices, pressure, electrical, and leak detectors) to facilitate analysis and ... repair of equipment and control systems.Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are carried out in accordance with established safety, GMP, and… more
- Aequor (MA)
- …high throughput gene synthesis and plasmid production, process automation and protocol development, improvement of quality and throughput, problem solving etc. Key ... responsibilities for position About growing with us for winning with us In this role you will : Independently plan, design, and execute synthetic biology experiments to construct and prepare high quality of nucleic acid material for mRNA vaccine production.… more
- Merck & Co. (Rahway, NJ)
- …and accountable for establishing the timelines for clinical supply needs per protocol and ensuring a robust signal for packaging and distribution for Clinical ... Finished Goods (CFGs)-Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. -Responsible and accountable… more
- Merck & Co. (Rahway, NJ)
- …for the clinical supply budget for respective program(s) and for supporting all protocol and program cost estimates requested by Product Development Teams . - ... Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or participate in… more
- Merck & Co. (South San Francisco, CA)
- …with external vendors and partners, on activities related to study design, protocol development, study execution, reporting and interpretation of data. Maintain a ... comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions. Work closely with pharmacometrics team members and provides input related to analysis and reporting of modeling activities.… more
- Merck & Co. (Chicago, IL)
- …to patient enrollment and retention efforts to achieve study milestones. Protocol lead responsibilities in collaboration with GCTOAddresses questions from ... investigators and provides information regarding participation in Company-sponsored clinical studies. Scientific Congress Support Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both Company and competitor… more
- Merck & Co. (Rahway, NJ)
- …interprets results from clinical trials to meet objectives of the study protocol .- Independently applies and implements basic and complex techniques to these ... analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.Provides responses to queries relating to study design, analysis, and… more
- Merck & Co. (North Wales, PA)
- …and interprets results from experiments to meet objectives of the study protocol .- Independently applies and implements basic and complex techniques to these ... analyses.--8. Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Management, regulatory agencies, or individual investigators.9. Provides responses to queries relating to study design, analysis, and… more
- Aequor (Thousand Oaks, CA)
- …quality, fit for purpose dataset - plan, build, review with the end in mind ( protocol - data collection - data review - analysis - archive) New Technology Design and ... Implementation: Evaluate new data management tools and technologies (eg, EDC systems, data integration platforms, data flow). Participate in system design, and user acceptance testing. Role model with staff on new technologies and ensure smooth integration… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and validation activities of new equipment and systems. Responsibilities include verification protocol execution (FAT, SAT, DQ, Commissioning, IQ, OQ, & PQ), data ... analysis and final report preparation Participate in the development and implementation of procedural or automation improvement changes Participate in design and hazard reviews of plant expansions or process changes and serving as the technical point of… more
