- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs ... for authoring the Clinical Supplies section of the study protocol as well as preparation and presentation of the...the clinical supplies information at Investigator Meetings for assigned protocols . - Support the collection of clinical suppl y… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …demographic/representativeness of samples from clinical trial and screen failures.Clinical trial protocol development and reviews (clinical trial protocols and ... diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to… more
- Genmab (NJ)
- …Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols , statistical analysis plans, results meetings presentations and clinical trial ... applicableCTT member:Participate and represent BiostatisticsReview and provide input to protocol and amendment development Perform vendor oversight according to… 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 ... level. Reviews and oversee completion of clinical trial protocols . Provides medical and/or scientific direction to Clinical Operations. Represents Clinical… more
- Genmab (NJ)
- …Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols , statistical analysis plans, results meetings presentations and clinical trial ... ICH-GCPCTT member:Participate and represent BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable… more
- Merck & Co. (Rahway, NJ)
- …team including Clinical Scientists 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… 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 ... user and functional requirements specifications, and necessary FAT and SAT protocols Maintain effective communication and ensure alignment in coordination with… more
- Merck & Co. (Rahway, NJ)
- …for the clinical trial planning, execution, and reporting.Develops individual protocols and data analysis plans and determines appropriate statistical methodology ... interprets results from clinical trials to meet objectives of the study protocol .- Independently applies and implements basic and complex techniques to these… more
- Merck & Co. (North Wales, PA)
- …trials, proposes solutions, and carries them out.3. Develops individual protocols and data analysis plans and independently determines appropriate statistical ... and interprets results from experiments to meet objectives of the study protocol .- Independently applies and implements basic and complex techniques to these… 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. (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. (North Wales, PA)
- …consultants to write, coordinate, and validate as required, study designs, protocols , measurement questionnaires, case report forms, data analysis plans, and final ... the Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.Supports affiliates to understand local needs,… 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
