- Merck & Co. (North Wales, PA)
- …heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial ... used to ensure the right data is collected from trial participants, in the right way to enable the...support drug applications and regulatory submissions to health authorities globally. Trial Data Management (TDM) is a core business capability… more
- Merck & Co. (North Wales, PA)
- …ResponsibilitiesResponsible for the operational planning, feasibility, and execution of a clinical trial .May serve as the clinical trial team leadMay lead team ... planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates,… more
- Merck & Co. (North Wales, PA)
- …field plus 12 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 10 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Merck & Co. (North Wales, PA)
- …and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... field and at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal skills and ability to negotiate and… more
- Merck & Co. (North Wales, PA)
- …of status update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead. -Leads team for timeline management, risk identification and ... site selection criteria with cross-functional team.-Works closely with Global Trial Optimization (GTO) to: develop patient recruitment and retention initiatives;… more
- Merck & Co. (North Wales, PA)
- …oral presentations and written reports to effectively communicate clinical trial results to the project. team, company Management, regulatory agencies, ... activities for innovative statistical methods and applications in clinical trial development.Education Minimum Requirement: PhD in statistics/biostatisticsOr a Master's… more
- Merck & Co. (North Wales, PA)
- …Teams, Early Development Teams; Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling team; Biostats, ... in pharma or similar industry setting.Required:Must have experience in clinical trial development and execution; clear strategic view on the Translational needs… more
- Merck & Co. (North Wales, PA)
- …Data Tabulation Model (SDTM)-A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and ... retrieval) and worldwide regulatory data management and reporting requirements.Strong knowledge of the Drug Discovery Process, ICH and GCP guidelinesKnowledge of Analysis & ReportingExceptional communication (oral and written) skillsMust have an innovative… more
- Catalent (Philadelphia, PA)
- …to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.Includes review of material status, protocol conformance, clinical design layout, ... ensuring blinding techniques are followed.Primary liaison with client for batch release.Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …and the appropriate patients that would benefit in order to ensure early trial and utilization Generates advocacy for Novo Nordisk products and services by sharing ... approved clinical and scientific information and insights with target physicians Recognizes opportunities to productively challenge HCPs clinical management of patients that respects their knowledge and experience and adds value by sharing new information and… more
