- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and ... rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has...assess and plan for Ph I - III study team delivery and transitions. This includes engagement with feasibility,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …living. Are you ready to make a difference? The Position Drive study management activities and manage cross-functional study team , external service providers ... focused approach, leveraging competencies, tools and technology, and with change management skills. Relationships Reports into North American Clinical … 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… 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 ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...other relevant GOMA functions and the Global Medical Affairs Team . Regional and Functional Support Work with the Functional… more
- Merck & Co. (North Wales, PA)
- …set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... direction of the Program Lead, you will collaborate with global, cross- functional team -members including clinical directors and study managers to lead/support … more
- Merck & Co. (Rahway, NJ)
- …checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS). Leads and participates in the review of ... transfer of electronic data files into the Clinical Data Management System (CDMS)....teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables. Leads and participates in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managers (LoBMs) and individual contributors to ensure effective performance management , team collaboration, employee engagement, and recognition. Ensures ... collaboration and role consistency. Accountability for quality and performance related managing clinical trial sites (ie data quality, document handling, and… more
- Merck & Co. (North Wales, PA)
- …and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Merck & Co. (Rahway, NJ)
- …ensures continuity of site relationships through all-phases of the trial.-Performs clinical study site management /monitoring activities in compliance with ... site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Product Development Plan and clinical development strategy; Leads Integrated Project Team (IPT) working closely with Global Project Management to ensure ... ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs...Team (IST) representative or IST leader on study team ; Responsible before senior management for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …risk minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teams - Collaborates ... with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical… more
- Catalent (San Diego, CA)
- …level. Use mathematical and scientific reasoning ability to identify aberrant data and potential quality/compliance concerns escalating to management .Excellent ... Quality Assurance Associate, Clinical SuppliesPosition Summary: Catalent Pharma in San Diego,...conform to established standards and agency guidelines.Ensures gathering of data , investigations and deviations are timely and compliant. Follows… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Insmed Incorporated (Bridgewater, NJ)
- …analysis. Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, coding, ... will play an important role in working with the team to execute the global clinical development...knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … data management (DM) expertise and guidance to the project team regarding the data management DM activities and deliverablesEstablishes ... (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent ... each CRO to best support each program. This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs, Regulatory Affairs and other ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...including NNI Evidence Generation Plans and Product Development Plans Clinical study management : Provide regional medical &… more
- Option Care Health (Columbus, OH)
- …manage this system and review such data to create marketing reports for Management Team and base sales campaigns upon such data .Successfully provide ... etc., and Hospital Nursing Staffs (Antepartum Units/Labor & Delivery, etc.)Works with Management Team to create marketing campaigns, create marketing materials… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) ... Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing the defined,… more
