- 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. (North Wales, PA)
- …appropriate by managementEducation Minimum Requirement: Bachelors degree with 1 year of clinical data management or standards experienceOrAssociates degree ... Operating Procedures (SOPs).Able to work independently or as a team member with equal effectiveness. Interacts with staff across...with 3 years of clinical data management or standards… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in a pharmaceutical, biotech company, or similar environment with extensive Clinical Data Management (CDM) and Standards experience, hands-on ... developments. This position provides expertise within the Biostatistics and Data Management teams by having the Medical...to support the collection of diverse clinical data .Participate in data standards team … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and ... those objectives. -Under the guidance of the Regional Director, Clinical Quality Management (RCQM), and in collaboration...agreement with the RCQM, presents trend analysis on QC data to the GCTO Leadership Team of… more
- Novo Nordisk Inc. (WA)
- …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
- Tris Pharma (Monmouth Junction, NJ)
- …salary commensurate with experience. The position is a core member of the Clinical Development management team responsible for developing and implementing, ... technology.Our science and technology make us unique, but our team members set us apart; they are the engine...(CRO) and/or Medical Writer to contribute to drafting of clinical study reports and other reporting data … 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
- Merck & Co. (North Wales, PA)
- …to support drug applications and regulatory submissions to health authorities globally.Trial Data Management (TDM) is a core business capability that focuses ... data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data...strategy to enable the software products within the Trial Data Management area to power the business… more
- Merck & Co. (Rahway, NJ)
- …or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding ... achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical...commitment to innovation and to our people. As a team , we commit to creating a culture of diversity… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... from the world's biomedical literature in support of regulatory, clinical research, marketing, and legal functions.- Plans, organizes, monitors, coordinates,… 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
- Insmed Incorporated (Bridgewater, NJ)
- …designing clinical pharmacology programs and studies, performing PK and PKPD data analysis, supporting clinical dose selection and authoring summary and ... of abstracts and manuscripts for publicationClosely partner with Research, Clinical teams, Bioanalytics, Regulatory, Project Management , and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other ... This individual will ensure proactive safety monitoring and risk management through the Safety Management Team...as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies from end to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to ... multiple program-level CS Asset Leads who are managing a team of clinical scientists for the writing...or several programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... IND.Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management .Lead the creation of the CRO scope… 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)
- …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)
- …/ Senior Manager, Data Programmer is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and ... trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as… more
