- Alternate Solutions Health Network LLC (Columbus, OH)
- …visit results.Policies: Completes all clinical documentation following agency protocol and Medicare/Federal guidelines.Rules and Regulations: Understand and follow ... agency policies, procedures, rules, and regulations and communicate changes in schedule/availability to schedulers or supervisors.Operations: Attend in-service training and mandatory agency meetings.HARD & SOFT SKILLS:Compassionate communicator with a positive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review per Integrated Data Review PlanAccountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose ... sections in collaboration with the other authoring functionsAccountable for Protocol content/study design developmentContributes from a medical strategy standpoint… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities conducted by CROs and vendors.Provide operational input into study protocol profiles, final protocols and amendmentsLead document review & coordination ... for the protocol and amendments. Additional medical writing tasks may involve...and delivery of study team plan and milestones (eg protocol , eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.). The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …representative or delegate at key R&D forums/groups such as Development Review Forum (DRF), Protocol Review Group (PRG) and SCORE. As a core or extended member of ... and other functions) to implement clinical development plan: study ideation, protocol development, review case report from creation, study initiation, study conduct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …per Integrated Data Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose ... in collaboration with the other authoring functions- Accountable for Protocol content/study design development- Contributes from a medical strategy standpoint… more
- Merck & Co. (North Wales, PA)
- …scientific-activities.Job ResponsibilitiesResponsible for the clinical/scientific execution of clinical protocol (s).Serves as the lead clinical scientist on the ... monitoring team in review and interpretation of clinical data/medical protocol -deviations in collaboration with the Clinical Director.Builds talent and capabilities… more
- Merck & Co. (Rahway, NJ)
- …adjudication support, preparation of meeting materials). - Support development of Protocol and related study materials (eg, ICF documents/amendments, data management ... Participate in CRF design to ensures data collection is in alignment with the protocol . You will be part of a diverse, cross-functional team of individuals who… more
- Shimadzu Scientific Instruments (NC)
- …able to make effective and efficient independent decisions per company policy and protocol to solve problems based on customer needs and requirements. This role must ... to maintain proper housekeeping and safety standards in-particular to laboratory safety protocol . Proper use of personal protective equipment and safety devices as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission documents; Point of contact for ... checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and other functions) to implement clinical development plan: study ideation, protocol development, review case report from creation, study initiation, study conduct ... May serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP development, other Clinical (oncology) Development line function… more
- Novo Nordisk Inc. (WA)
- …of data collected at clinical trial sites in accordance with the protocol , Monitoring Plan and other associated trial documents Complies with relevant training ... of medical and scientific concepts in order to effectively interpret protocol requirements, support sites and effectively conduct monitoring activities. The CRA… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …collection methodologies for faster EDC design and build aligning with protocol data collection objectives.Responsible for the development and maintenance of Daiichi ... with an understanding of the complex and interdependent relationships between protocol development, data collection, CRF designing, analysis and reporting preferred4… more
- Merck & Co. (North Wales, PA)
- …interprets results from clinical trials to meet objectives of the study protocol .- Independently applies and implements basic and complex statistical techniques to ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, company Management, regulatory agencies, or individual investigators.Provides responses to queries relating to study design, analysis,… more
- Catalent (St. Petersburg, FL)
- …Clinical Packaging Protocols, Process assessment, Method Validation, Bulk Mfg Protocol and Reports (non-GMP, Clinical, Registration, Process Validation, Product ... Transfer, etc.), Risk Assessment, Formulation Reports, Development Reports, Material Evaluation Requests, Material and API Specifications; Product specifications; Test methods; b) RTE, Process improvement projects and Product Development Projects; c) Stability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …eg for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Review CRF; Write SAP; Manage ... oversight of vendor delivery, to ensure compliance with the protocol , external/internal standards, applicable regulatory guidelines, Policies, SOPs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key submission documents; Point of contact ... checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing process transfer plans, protocols, and reports. Design studies, draft protocol , oversee execution and draft reports necessary to support the ... of change controls. Provide review of process flow diagrams as well as protocol and reports from development. Support the implementation of manufacturing and process… more
- Merck & Co. (Rahway, NJ)
- …PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide ... predictability.Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.Attend local Investigator Meetings if requested to.Interface with GCTO partners on clinical trial… more
- Merck & Co. (Rahway, NJ)
- …investigator, specifically experience with investigator-initiated studies, concept assessment, and protocol reviewProven ability to work in a complex matrix ... environment and effectively operate in a team-oriented structureAdvanced facilitation and consultative skillsAbility to effectively interact with internal and external stakeholders and to positively influence decision making at a senior levelExcellent… more
