- Aequor (NJ)
- …site level according to study (and IRT) requirements. Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs ... 100 % remote Manager prefers local candidates (will consider non local...bachelor's degree Must Haves: Phase 1 to 4 clinical trial experience Managing end to end supply chain Job… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership with Functional and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end ... collection of diverse external data types.Advises Study Data Manager on complex vendor management...disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs ... This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …represents function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance ... meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in one or more key functions (eg, clinical research, clinical operations, data management , biostatistics, project management ) required- Collaboration, ... Management to respond to process metrics and trending data to identify gaps, and design/implement process improvements.-monitor and evaluate risks/issues… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ownership… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, ... and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables;… more
- Merck & Co. (Irving, TX)
- …305, DHIA plus, PCDart etc)Experience with dairy sensor technologies and use of data to make management decisionsFluent in English and Spanish#EBRGNOTICE FOR ... CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all phases of the trial .Performs clinical study site management /monitoring activities in compliance with ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager throughout all phases of… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all-phases of the trial .Performs clinical study site management /monitoring activities in compliance with ... Job DescriptionWith support of Sr CRA (Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to improve organizational efficiencies and cost controls.Communication and Relationship Management - Leads contract related communication with vendors. Respond to ... appropriate utilization and application of advanced negotiation skills, partnership management and strong interpersonal skills to support and advance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Reports to Associate Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop comprehensive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality risk management process. Interact with the audit function. The respective Data Management groups and respective CROs in order to ensure high ... QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission… more
- DivIHN Integration Inc (San Diego, CA)
- …to work 100% in person and have experience working with biological specimens and data sets, ideally with some clinical trial familiarity Will be providing ... one of our Talent Specialists Sivanesan at 224 369 0756 Title: Clinical Trial Assistant (CTA) Location: San Diego, CA Duration: 12 Months Description: Candidates… more
- EY (New York, NY)
- …of clinical trial regulatory and submission processes.Familiarity with clinical trial data management systems.Strong analytical thinking and ... and physical data models aligned with conceptual data modelsDevelop, organize, and manage clinical trial ... and systems architecture (APIs, messaging, etc.)Experience with master data management and data governanceExperience… more
- HITT Contracting (Falls Church, VA)
- The HITT Safety Manager is responsible for the safety performance and safety development of their assigned business units and direct reports. This individual is a ... safety inspections utilizing Predictive Solutions System independentlyEvaluate hazard and incident data to identify trends and create focus on specific project and… more
- Russell Tobin & Associates (San Diego, CA)
- What are we looking for in our R&D Quality Risk Management Manager ? The Scientific Team at Russell Tobin & Associates is supporting an exciting pharmaceutical ... that has an opening for an R&D Quality Risk Management Manager near San Diego, CA! Responsibilities...with drug development process - clinical protocol development, global trial management and monitoring, drug safety, biostatistics… more
