- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …per Integrated Data Review Plan (IDRP)Accountable 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. (Bernards, 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. (Bernards, NJ)
- …all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, exploratory, etc.). This position ... data structure deviations or validation issues. Complies with the protocol , Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs),… 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 ... data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Merck & Co. (Rahway, NJ)
- …as a co-author for drafting relevant biomarker sections of clinical study protocol Work closely with Translational Molecular Biomarker (TMB) Scientist to manage ... and storage guidelines that align with the Biomarker plan and clinical study protocol . Accountable for providing biomarker vendor assay statement of work and data… more
- Merck & Co. (Rahway, NJ)
- …activities.Job Responsibilities Responsible for the clinical/scientific execution of clinical protocol (s).Serves as the lead clinical scientist on the clinical trial ... monitoring team in review and interpretation of clinical data/medical protocol -deviations in collaboration with the Clinical Director.Builds talent and capabilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management areas including Reception, Facilities Services, Amenities and Events, and Security Protocol . This position will be knowledgeable to perform a wide variety ... corporate projects including maintaining and updating emergency and safety protocol documents, maintenance of visitor logs and phone/employee listsFacilities… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …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. (Bernards, NJ)
- …This position works under supervision to solve complex study problems.Responsibilities: Protocol Development, Case Report Form (CRF; review), Statistical Analysis ... activities for low to medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …monitoring activities as per the plan Manage all required local protocol amendments/deviations Assist in the recruitment of investigators for clinical studies ... and provide medical support to investigator meetings Provide protocol training, disease specific training and titration training Assure timely initiation of studies;… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …degree in a science discipline or a related field.Expertise in scientific protocol and consent form writing/editing, as well as working with IRBs for ... protocol management across the study lifecycle. Demonstrated expertise in technical and scientific writing.CCRP, CIP or related clinical research/IRB… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …works under some supervision to solve complex study problems. Responsibilities Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical… more
- Daiichi Sankyo, Inc. (Bernards, 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
- AAOS (Rosemont, IL)
- …secured, and confirmation numbers are shared with the Board of Directors per protocol . Works closely with Team Members to oversee specialized aspects relating to ... Oversees the development of the annual Presidential Line travel protocol guidebook relating to international travel. Reviews international meeting schedule… more
- Aequor (Thousand Oaks, CA)
- …Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. Protocol and report authoring according to regulatory and industry guidelines ... (ie, ICH) and data analysis will be a core activity in this role. This individual may support other clinical and commercial locations throughout the company under the guidance of project leads.Basic Qualifications: Pharma or Biotech Master's degree and 2 years… more
- Merck & Co. (Durham, NC)
- …technical 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 higher Required Experience and Skills: At least two (2) years GMP… 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
- 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 two (2) years of GMP manufacturing/processing… more
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