- 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 chain… more
- Insmed Incorporated (San Diego, CA)
- …with the Clinical Trial/Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or projects, partnering with vendors and cross functional teams. The ... to scientific and operational aspects and stages of the protocol development and study execution, from study design planning...and materials for meetings as it related to the protocol (s) and program Provide protocol level scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …per Integrated Data Review Plan (IDRP)Accountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose ... the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent with CDP and aligned to achieve the Target Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary Drafts development plans, protocol profile, protocol , and clinical sections of submission documents ... risks to study deliverables; development of contingency plan; development of protocol profile, protocol , and ICF template; selection of ARO, CRO, and members for… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation ... and associated CAPA plansAuthors, owns and executes master and completed CQV protocols , summary reports and associated data for conformance to regulations, SOPs,… 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
- Insmed Incorporated (San Diego, CA)
- …of tissue.Use of cryostat to generate slides for histology.Execute staining protocols (eg. H&E) as well as immunohistochemistry.Documentation of results in ... study graphs and survival curves.Experience organizing experiments and performing protocol writeups for developing R&D experiments.Knowledge of Good Documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS ... Goals and Procedure Development: Assist Leadership to ensure compliance with protocol and internal/external standards. Identifies and drives strategy for process… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …assessments, 3) Analyzing data to assure data integrity, quality control and protocol compliance, 4) Training and supervising research staff and student volunteers, ... knowledge of psychological, socio-behavioral and/or neurobehavioral research principles, practices and protocols as well as knowledge of the principles, methods, and… more
- Aequor (South San Francisco, CA)
- …these methodologies is desirable, but not required. Maintaining documentation related to protocol execution and results. Writing protocols and contributing to ... final reports as appropriate. Adhering to departmental SOPs to ensure study integrity and quality. Conducting experiments with a high level of independence and initiative. Performing tasks with minimal direct supervision for routine methods and studies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …limited to cross-functional team meetings, project team meetings and observational study protocol reviews. One of the key responsibilities for the fellow is leading ... cross functional internal stakeholders as part of research projects. Prepare protocols for internal approvals and engage reviewers during approval process.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the outsourced and in-house operating models. Complies with the protocol , Policies, SOPs, external/internal standards, Good Clinical Practices (GCPs), applicable ... of Medical Coding to gain resolution. Functional Expertise:Study Start-Up: Reviews protocol to identify need for specific medical coding conventions. Drafts medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Study Associate Manager within Clinical Operations, in adherence to the protocol , Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), ... and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.Compile… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan ... Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical… more
- Genmab (Plainsboro, NJ)
- …and align CTT goals collaboratively with the teamReview and approve protocol and amendment changesReview the Master Informed Consent Form (ICF)Approve operational ... the country selection processCoordinate responses to IEC/IRB commentsMonitor major protocol deviations (PDs) and trendsApprove data cleaning plansCollaborate with… more
- Aequor (Fort Worth, TX)
- …Review laboratory data. Skills: The ability to work independently following an approved protocol The ability to function in a team environment The flexibility to ... work overtime as required by the aggressive project schedule Good technical writing skills and the ability to communicate technical issues to project lead and team Good time management and organizational skills. Education: Bachelors of Science degree in… more
- Merck & Co. (Durham, NC)
- …and OPEX functions such as Kaizen events, ad-hoc sampling, or protocol execution.Maintains detailed knowledge of equipment and processes.Identifies and addresses ... compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.Education Minimum Requirement: High School Diploma/GED or higherRequired Experience and Skills: At least one (1) years of GMP… more
- Merck & Co. (Rahway, NJ)
- …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 Compound Management Coordination activities.- - Support the collection of clinical supply chain metrics and/or… more
- Genmab (NJ)
- …and reviewer of clinical and regulatory documents and registration dossiers (ie, protocol , ICF, IB, safety updates, study reports, regulatory submissions, etc.) to ... support registration and commercialization of the compound(s) Contributes in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (eg database lock activities).… more
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