- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and ... research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical ... including veterans and people with disabilities. Summary The Associate Director , External Data Management , is...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Tris Pharma (Monmouth Junction, NJ)
- …personnel selection including, but not limited to: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, ... in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director ,...the organization and by applying overall and specific project management and organizational leadership expertise to the clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (North Wales, PA)
- … clinical data /medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Insmed Incorporated (Bridgewater, NJ)
- …statistical analysis. Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs, Regulatory Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs ... drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders… more
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... programs/tools to facilitate the statistical analysis of biomedical or related data .Demonstrated excellence in complex project management , showcasing the ability… more
- George Washington University (Washington, DC)
- …the GW School of Medicine and Health Sciences is seeking an Assistant Director , Business Operations Clinical Research, SMHS. This position manages all pre-award ... Epic, and facilitates with post award financial team, as needed. The Assistant Director reports to the Chief of Clinical Research Administration and Operations,… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …of improving the health of our communities. About the Role:Job SummaryThe Director of Cardiovascular Clinical Business (the Department) is responsible and ... Director and be responsible for facilitating performance improvement data reporting and tracking. #LI-KR1#NGHSJOBS Minimum Job QualificationsLicensure or other… more
- Merck & Co. (Rahway, NJ)
- …products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a subject matter ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Merck & Co. (North Wales, PA)
- …least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source...the selection of appropriate journals and congresses for scientific data dissemination. They work closely with both internal writing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …placement and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management : Build strong internal and external… more
- Eisai, Inc (Nutley, NJ)
- …and Clinical Operations. Essential Functions Work with key stakeholders, management , and functional area leads to develop strategic and aligned Medical Affairs ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Novo Nordisk Inc. (Chicago, IL)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Tris Pharma (Monmouth Junction, NJ)
- …reports, periodic benefit risk evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases Ensures audit ... success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning,… more
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