- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities Prior TMF experience required!-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work in a ... Clinical Operations Department that manages multiple early-late stage clinical programs. The Senior CPM will be...in the development of tools and metrics for monitoring clinical study progress and surveillance of key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... Budget; Establishes effective communication between CRO / vendors / AROAdditional non- study related activities: Occasional senior management interactions at… more
- Merck & Co. (Rahway, NJ)
- …Metabolism projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study ... development plans, and to ensure optimal trial design and monitoring of studies , producing high-quality clinical documents and presentations. The position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …goals, including those specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio. Assists in creating, leading ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Merck & Co. (Rahway, NJ)
- …and programs.In collaboration with internal teams and external partners, design studies , author study protocols, develop measurement questionnaires, case report ... improve patient health outcomes. Under the guidance of a senior leader, this individual will support the V&I, Outcomes...forms, data analysis plans, final study reports, scientific presentations, and publications.Responsible for study… more
- Merck & Co. (Rahway, NJ)
- …standards development teamsThe Vocabulary Specialist maintains knowledge of new technologies, clinical study data standards, regulatory requirements emerging in ... Job DescriptionThe Global Clinical Data Standards Vocabulary Specialist, Associate ...across GCDS by actively communicating and proactively sharing informationSupport senior /leadership roles, in areas of observed competence, to enhance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and budget negotiations through understanding and tactics to develop, execute and deliver clinical studies /programs on time with a focus on budget, compliance ... you ready to make a difference? The Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Research, secondary data analytics, searching and reviewing scientific literature, clinical trial data, journal studies Progressive demonstrated business ... ready to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include leading… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates...product labeling as it relates to the use of study results in US promotion.Maintain current awareness of evolving… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Senior Associate , Clinical Contracts & Budgets** **What you will do** ... Let's change the world. In this vital role the Senior Associate , Clinical Contracts &...+ Responsible for the contracting process for locally outsourced studies + Ensure signature process is complete + Storage… more
- Avania (OR)
- Avania are hiring for the key role of Senior Clinical Research Associate (Sr CRA) Working for Avania is working in a diverse environment; from performing ... knowledge, build an open communication and comradery. As a Senior Clinical Research Associate (CRA)...site management and close out activities. + Be the study lead for several studies + Act… more
- System One (Dallas, TX)
- Senior Clinical Research Associate - Regional Location: Home Based, Dallas, TX Type: Full time Start Date: ASAP Are you an experienced Clinical Research ... working for a sponsor, in a therapeutically aligned model supporting Endocrinology studies , conducting remote and onsite monitoring of regional sites in a risk-based… more
- WuXi AppTec (Austin, TX)
- …position within the Operations team and is assigned as a study lead to manage clinical trial studies . The Senior CRA will partner with a Project Manager ... every disease can be treated." **Responsibilities** **Job Summary:** The Senior Clinical Research Associate is...teams, liaise with other functional areas to accurately coordinate clinical study activities + Coordinate clinical… more
- Pfizer (Collegeville, PA)
- …plans, including data preparation and validation activities, among others. As a Senior Associate , your knowledge and skills will contribute towards the ... Clinical Practices + Thorough understanding of the processes associated with clinical study management and regulatory operations + Ability to manage tasks,… more
- BeiGene (Emeryville, CA)
- …a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance ... ICH-GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical … more
- IQVIA (Overland Park, KS)
- …other required study documentation. * Act as a mentor for clinical staff including conducting co-monitoring and training visits. * Collaborate and liaise with ... Overview Perform monitoring and site management work to ensure that sites are conducting the study (ies) and reporting study data as required by the study … more
- Kelly Services (Irvine, CA)
- ** Senior Clinical Research Associate ** **(Cardiovascular/Electrophysiology - Medical Device)** **Travel: 60-70% - Expectation is 10-12 days a month out of ... of appointed study sites, conducting company initiated clinical studies . Responsible for the site visits, monitoring, communication, and deliverables… more
