- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The RoleAs Senior Clinical Trial Associate (Sr CTA) you play a key role in supporting Clinical Trial Team ... study documentation, regulatory compliance, communication between stakeholders, and overall trial coordination. This position is essential for maintaining high-quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Regional Head manages all aspects of clinical trial operations in the region and reports to the Global Head of Global Clinical Trial ... ready studies is essential. The position is responsible for trial quality and audit responses and completion of Corrective...ensures a single point of contact for managing clinical trial execution in all its aspects across phases I/II… more
- Merck & Co. (Rahway, NJ)
- …high-quality, inspection ready studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures ... a single point of contact for managing clinical trial execution in all its aspects across phases in...Management:Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct ... regulations such as site and vendor selection, preparing clinical trial budgets. Ensures study is conducted within clinical ...trial budgets. Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team… more
- Merck & Co. (North Wales, PA)
- …ecosystem, under guidance of staff with extensive expertise in clinical trial A&R standards development.Provides technical consultation and analytical support to ... environment under guidance of staff with extensive expertise in clinical trial A&R standards development.Educational Qualifications:Must have a Master's degree in… more
- Merck & Co. (Rahway, NJ)
- …support for Clinical Development Sourcing and Procurement (CDSP) in C linical Trial Central Labs. This includes sourcing of clinical services utilizing the Sourcing ... This role will report to the Associate Director, Clinical Trial Central Labs to support high quality sourcing initiatives...and suppliers in the context of a challenging clinical trial environment.Must be adaptable in dealing with ambiguous and… more
- Merck & Co. (North Wales, PA)
- …field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
- Merck & Co. (Rahway, NJ)
- …Clinical Research group. He/she will be responsible for all phases of the trial process, including but not limited to the design, oversight and medical monitoring ... as well as analysis, interpretation, and reporting of final clinical trial results.Responsibilities also include the presentation of research findings at national… more
- Merck & Co. (Rahway, NJ)
- …preferred.Ability to prepare, with minimal oversight, a summary of a clinical trial design, objectives and activities for a lay audience per established guidelines ... Clinical Operations, Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance, Clinical Trial Management, Critical Thinking, Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.Clinical trial protocol development and ... reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samplesProject Team Participation: Provide device-specific regulatory insight/guidance during CDx… more
- Merck & Co. (North Wales, PA)
- …related field plus 5-9 years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, ... related field plus 3-7 years SAS programming experience in a clinical trial environment - Department Required Skills and Experience: Effective interpersonal skills… more
- Genmab (NJ)
- …of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and ... allocation process of a program and/or study.Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV, including health… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Accountable for inspection readiness of laboratory data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory ... data expertise to promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to ensure all laboratory data management… more
- Merck & Co. (North Wales, PA)
- …field plus at least 7 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer Science, Statistics, Applied Mathematics, ... or related field plus 9 years SAS programming experience in a clinical trial environment. Required Skills and Experience: Experience in CDISC SDTM and ADaM standards… more
- Eisai, Inc (Nutley, NJ)
- …a senior leadership role responsible for overseeing all aspects of clinical trial execution within a pharmaceutical or biotechnology company. This role ensures ... (IPTLs). This role requires a deep understanding of the entire clinical trial process, from initial planning and protocol development through to study close-out… more
- Merck & Co. (North Wales, PA)
- …plus at least 3 years SAS programming experience in a clinical trial environment.OR a bachelor's degree in computer science, Statistics, Applied Mathematics, Life ... plus at least 5 years SAS programming experience in a clinical trial environment.Positions Required skills and expereince:Must have experience in CDISC and ADaM… more
- Merck & Co. (North Wales, PA)
- …efforts to achieve study milestonesUpon request from Global Clinical Trial OperationsRecommends study sites and identifies potential investigators to participate ... study milestones.Protocol lead responsibilities in collaboration with Global Clinical Trial OperationsAddresses questions from investigators and provides information regarding… more
- Merck & Co. (Rahway, NJ)
- …models, quantitative system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to improve cycle time, ... analyses, model-based meta-analysis, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to ... and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution… more
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