- Merck & Co. (North Wales, PA)
- …systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine ... assurance of deliverable quality and process compliance,effective deliverable development utilizing global and TA standards that optimize analysis and reporting… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Merck & Co. (North Wales, PA)
- …of therapeutic areas- specific standard Tables, Listings, Figures (TLF) libraries-Facilitate global adoption of therapeutic areas standards and programming best ... programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and therapeutic area standards and according to quality,… more
- Merck & Co. (North Wales, PA)
- …device/combination product documentation to support regulatory filings and audits of data , policies, procedures, and systems to ensure compliance with Medical Device ... Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing… more
- Insmed Incorporated (Philadelphia, PA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along… more
- Pfizer (Collegeville, PA)
- The Global Clinical Lead is a leadership role that represents clinical development on the Medicine Team as the single point of accountability for clinical ... heart failure and other cardiovascular indications. + Leads the Global Clinical Team towards the common goal...intended for external publication that are based on Pfizer-sponsored clinical trials + Interprets clinical data… more
- Organon & Co. (Plymouth Meeting, PA)
- …The leadership of the following teams: Global Clinical Development (GCD), Clinical Trial Operations (CTO), Clinical Data Sciences (CDS) that includes ... following teams: Global Clinical Development, Clinical Trial Operations, Clinical Data ...assure adequate quality and consistency with company and industry standards . + Develop a thoughtful data management… more
- Merck (North Wales, PA)
- …+ Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). + Contribute to the development ... . It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the … more
- CSL Behring (King Of Prussia, PA)
- …vendors that can conduct central lab activities and sample testing to support important global clinical trials. Accountable for oversight of clinical samples ... and ensuring quality of data is validated protocols. + Manage clinical samples per country regulations and informed consent procedures. Capability to manage… more
- J&J Family of Companies (West Chester, PA)
- …In close collaboration with Clinical Affairs Leaders, identifies and ensures global clinical strategies, resources and accountabilities are in place to ... are conducted in compliance to all applicable regulations and standards , are on-time and within budget. This leader leads... studies, for the supported franchises delivering high quality clinical data to support Regulatory, Market Access,… more
- Pfizer (Collegeville, PA)
- …a focus on innovative design, medical and scientific excellence, and the highest ethical standards . He or she will lead clinical development strategy and program ... deep medical and clinical knowledge to translate clinical research ideas into high-quality decision-making data ,...addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0%… more
- Merck (West Point, PA)
- …forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug ... **Job Description** Our Company is a global health care leader with a diversified portfolio...Substance, Drug Product, Analytical Development, and Clinical Supply across all modalities. We are interdependent across… more
- CSL Behring (King Of Prussia, PA)
- …control process for SAS programs used to access, extract, transform, review and submit clinical data for all requested analyses. You will partner with other ... and statisticians to ensure the quality and accuracy -thus submission readiness -of clinical data by authorities (ie SDTM, ADaM, tables, figures, listings, and… more
- Merck (Upper Gwynedd, PA)
- …be programmed; an understanding of statistical terminology and concepts. + Familiarity with clinical data management concepts. + Hands on experience in CDISC and ... clinical studies using deep scientific knowledge, statistical analysis and high-quality data to assist decision making in clinical trials. This position… more
- Merck (North Wales, PA)
- …SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts. + US and/or worldwide drug or ... of deliverable quality and process compliance, + effective deliverable development utilizing global and TA standards that optimize analysis and reporting and… more
- Pfizer (Collegeville, PA)
- …studies and will be tasked with taking on responsibilities in support of Global Study Managers, other Study Operational Managers and the larger Study Management ... study. The Study Operations Manager may partner with the Global Study Manager, Study Start Up Project Manager, Site...or more studies, in accordance with the appropriate quality standards including ICH/GCP standards , SOPs, local operating… more
- Teva Pharmaceuticals (West Chester, PA)
- …the execution of the study from protocol concept to final report including interpretation of clinical data + Overseeing the Medical Monitor(s) for a study or ... protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.), reviewing study data and providing… more
- Merck (North Wales, PA)
- …to be programmed, an understanding of statistical terminology and concepts. + Familiarity with clinical data management concepts + Experience in CDISC and ADaM ... **:** + Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good… more
- J&J Family of Companies (Horsham, PA)
- …within partner organizations (ie Quality, Drug Product Development, Analytical Development, Global Clinical Operations). + Ensure TS&E activities are consistent ... PA, Titusville, NJ, or Beerse, BE. Within JJIM R&D, CSC holds the global responsibility for delivering all clinical supplies (Devices, API, Drug Product,… more
- Pfizer (Collegeville, PA)
- …of specialized and complex global development projects, must have knowledge of clinical design of experiments, clinical data management and programming ... registration projects. + Provide planning and communication of statistical analyses, data presentations and scientific reports, including clinical trial results,… more
