- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team ... Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study...data review process in collaboration with the study team to ensure data qualityParticipates in audits… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a ... Job DescriptionOur Clinical Research and Pharmacovigilance team push...growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and… more
- Novo Nordisk Inc. (San Antonio, TX)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Merck & Co. (North Wales, PA)
- …development of Protocol and related study materials (eg, ICF documents/amendments, data management deliverables).May interact with internal and external ... one or more clinical trials in the lung cancer program. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical … more
- Merck & Co. (North Wales, PA)
- …database 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- … clinical trial recruitment in collaboration with agency partners and the clinical trials team (includes core response documents; speaking guidance documents; ... resonate with target audiences and are clearLead regular reviews of analytics and data to optimize clinical trial paid media activationsShare clinical … more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... of our existing and pipeline products to produce safe, effective, innovative medicine.The Clinical Sciences & Study Management (CSSM) department is building the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... programs. Participates in the development of, and ensures adherence to, our company's clinical data management procedures. Interacts with staff across sites,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...minimum of 2 years of direct expertise of site management and logistical execution of clinical trials… more
- Merck & Co. (North Wales, PA)
- …agreements, and other type of agreements related to clinical research.Our Clinical Research and Pharmacovigilance team push the boundaries of global ... GSA Specialist you will work closely with experienced GSA team to:Review Clinical Outcome Assessment (COA) licensing...implementation of COA measures in connection with our company clinical trials through strong project management 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
- Tris Pharma (Monmouth Junction, NJ)
- …IDMS charter, statistical analysis plans, data management and safety management plans Ensures clinical data collection proceeds in a manner ... and technology make us unique, but it is our team members that set us apart; they are the...Case Report Form (CRF) design and data management processes; Performs periodic review of clinical … 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 ... as a subject matter expert and contributor to DM data standards team and represents function to...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… 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
- Option Care Health (Dublin, OH)
- …of services that are available through Option Care.Experience applying knowledge in the clinical management of home infusion patients as evidenced by documented ... formulas, and assessing laboratory values.Experience applying knowledge in basic patient management skills, clinical procedures and clinical documentation… 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
- 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
