• Merck & Co. (Rahway, NJ)
    …to other clinical scientistsRequired experience and skills: - Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH) - Ability ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. -In...clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Upper Gwynedd, PA)
    …ensures data collection is in alignment with the protocolCore SkillsWorking knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... the scientific planning and execution of one or- more clinical trials . Assists the Lead Clinical...and prioritization skillsAnalytical skills with the ability to interpret clinical trial dataand synthesize conclusionsInteract with key… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …assigned clinical trials , document management and management of clinical trial management systems and archiving systems. Relationships Reports to a ... for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research ... trials , including distribution of SUSARs to clinical trial sites Maintenance of systems, eg,… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    … and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with ... The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing;...principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills… more
    HireLifeScience (03/28/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …process, including working knowledge of all functional areas of clinical trials and medical terminology, FDA and local regulatory requirements, etc.Proven ... study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance...status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual… more
    HireLifeScience (02/16/24)
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  • Novo Nordisk Inc. (Los Angeles, CA)
    … and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with ... The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing;...principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …experience preferred- 4 or More Years 3 + years of experience with Clinical Trials Data, Genomics, Bio Marker & Regulatory Data preferred- 4 or More Years 4 ... capabilities like Data Lakes, Master Data Management, NLP Integrations etc. for Clinical , Regulatory & Translational Research . The candidate will have direct… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (North Wales, PA)
    …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these … more
    HireLifeScience (03/23/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    … & Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and ... community input Regulatory liaison: Write and/or review clinical sections of clinical trial ...area experience in diabetes, CV or Obesity required Prior clinical research or related experience (eg monitoring… more
    HireLifeScience (03/15/24)
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  • Insmed Incorporated (San Diego, CA)
    …Site.Experience managing people / teamsExperience managing various phases of clinical trials .Experience in global clinical trial conduct across several ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we.../ teamsExperience managing various phases of clinical trials .Experience in global clinical trial more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs...who contribute to the planning, conduct and reporting of clinical trials . Ensures business needs are met… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …focus mostly on pediatric regulatory documents and the execution of pediatric clinical trials . Qualifications: Successful candidates will be able to meet the ... submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to … more
    HireLifeScience (03/21/24)
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  • Merck & Co. (North Wales, PA)
    …in Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory , Early/Late Development ... Job DescriptionThe Department of Biostatistics and Research Decision Sciences (BARDS) is a key functional...and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical trial more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial -level regulatory documents (eg, response to ... a primary source of medical accountability and oversight for one or more clinical trials . Matrix management responsibilities across the internal and external… more
    HireLifeScience (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryLeadership responsibility… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (North Wales, PA)
    Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ... of- pharmacovigilance and risk management plans with direction/guidance from the Clinical Safety and Risk Management (CSRM) team.Assists the CSRM team to:-… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (North Wales, PA)
    clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical more
    HireLifeScience (03/22/24)
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  • Merck & Co. (North Wales, PA)
    …to facilitate initial approval by regulatory agencies for conduct of clinical trials .Participates in regulatory due diligence activities for licensing ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …and activities across CSO workstreams to support the business.Collaborating closely with Global Clinical Trial Operations (GCTO) and Regulatory teams to ... chain clinical supply packaging and distribution operationsExperience with clinical trial operationsFamiliarity with SAP Operations Management Certification… more
    HireLifeScience (03/15/24)
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