- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager...assigned, Sr . CSM may act as the Study Team Leader for the assigned clinical … more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of ... country teams, vendors, committees, investigators, site personnel, etc.) in support of clinical study objectives.- Accountable for managing any study … more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the… more
- Aequor (Thousand Oaks, CA)
- …regulatory guidelines impacting supply (ie GxP, SOX) High attention to detail Understanding of clinical study conduct Ability to operate in a team or matrixed ... remote schedule and be available at the committed times. Qualities/characteristics the hiring manager is looking for in candidates to work best with their team:… more
- Merck & Co. (North Wales, PA)
- …provides support across all elements of management and execution of non-interventional studies and research activities. This position, under the supervision of a ... Lead, will execute a variety of research management activities starting from study execution to close-out and summarization of results from observational research… more
- Novo Nordisk Inc. (Irvine, CA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately ... system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the Senior Manager , Medical Writing is from :126,300-165,800Under current… more
- Mindlance (Atlanta, GA)
- …projects, and with additional oversight as needed on complex or highly complex studies . Acts as a project manager , overseeing the statistical and programming ... Job Title: Sr Biostatistician Job Location: Remote Top 3/5 Skills:...to process improvement and departmental initiatives. . Serves as senior reviewer on simple or moderately complex studies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...the execution of the Audit Management Plan for assigned studies Responsible for health authority (eg, FDA) inspection preparedness… more
- Novo Nordisk Inc. (Albuquerque, NM)
- …and modify customer engagement and sales strategies Understand the most up-to-date clinical studies to educate customers and improve ability to anticipate ... maintain advocacy of customers aligned to company, brand and clinical goals. The OCS develops local strategies and executes...health. Internally, the OCS reports to the District Business Manager of the specific sales territory. The OCS also… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …access strategy for the assigned oncology asset(s). This person will report to the Sr Director, Global Oncology Value Pricing & Access, and will be responsible for ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access… more
- Sunrise System Inc (Atlanta, GA)
- …and Abilities: Knowledge of GxP requirements and experience with safety processing, clinical safety study reporting, PV and medical information preferred Ability ... Job Title: Sr . Associate, Aggregate Report Compliance Job ID: 24-02289.... Associate, Aggregate Report Compliance In conjunction with the Manager of Aggregate Report Compliance and Vendor Oversight, the… more
- DivIHN Integration Inc (Atlanta, GA)
- …within timelines. Clinical documents may include investigator brochures, protocols, clinical study reports, integrated reports, clinical sections of ... 224 369 2969 Sivanesan at 224 369 0756 Title: Senior Medical Writing Specialist (REMOTE) Location: Remote Duration: 6...the world. Part of the requirements is to produce clinical documents which support the safety and efficacy of… more
- Reynolds American (Winston Salem, NC)
- Sr Scientist Clinical Data Manager ...start-up through to database lock to receipt of final study outputs for clinical studies outsourced ... Come be the change!** **WE ARE LOOKING FOR A SR SCIENTIST CLINICAL DATA MANAGER **...Salem, NC** **ROLE POSITIONING AND OBJECTIVES** **Reports to** Director Clinical Studies **Number of Direct Reports** 0… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The successful Sr Clinical Project Manager (CPM) will lead cross-functional project teams to skillfully plan and execute ... clinical studies , from concept through ...clinical studies , from concept through study completion, in...self. Become a **maker of possible** with us. **The Sr . Clinical Project Manager will:**… more
- IQVIA (Durham, NC)
- **Join our team as a Senior Clinical Trial Manager in CVRM!** **A** **pply today and shape the future of healthcare!** We have an opportunity for a Senior ... Lead ( Senior Clinical Trial Manager ) with CVRM (Cardiovascular, Renal & Metabolism) to join...clinical operations plans and ensuring consistent use of study tools, training materials and compliance with standard processes,… more
- BeiGene (Emeryville, CA)
- …updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team ... Study Report in collaboration with Global Clinical Study Manager and Medical...and the quality of the work performed on assigned studies + Contributes to development, optimization and review of… more
- Stryker (Cary, IL)
- …million patients annually. More information is available at www.stryker.com We are currently seeking a ** Senior Clinical Study Manager ** , to join our ... regulations and expectations. **What you will do** As a Senior Clinical Study Manager...manuscript/presentation preparation. + Provide budget input aligned to planned clinical strategy for clinical studies … more
- Stanford University (Stanford, CA)
- Senior Clinical Research Manager **School of Medicine, Stanford, California, United States** **New** Research Post Date 6 days ago Requisition # 103407 ... Stanford University is seeking a Senior Clinical Research Manager to...of demonstrated managerial experience. + Demonstrated disease knowledge / study design experience of studies under purview.… more
