- Merck & Co. (North Wales, PA)
- …additional standards library componentsParticipate in standards data governance reviewsThe Global Clinical Data Standards (GCDS) Data ... related to the definition, use, maintenance and sharing of clinical data standards -Support department initiatives...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- 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 ... trial participants, in the right way to enable the Clinical Research to analyze data for efficacy,...initiation to first site ready.Remove obstacles and enable the Global Clinical Trial Organization to focus on… 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
- Merck & Co. (North Wales, PA)
- …and budget management, reference requests, bibliography management, posting of study data packages for author access and delivery of protocol documents to ... that department-managed documents and archives comply with established company standards .Develop and maintain publication SharePoint/EngageZone site for a therapeutic… more
- Merck (North Wales, PA)
- … library components + Participate in standards data governance reviews + The Global Clinical Data Standards (GCDS) Data Standards ... related to the definition, use, maintenance and sharing of clinical data standards + Support...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Merck (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 ... trial participants, in the right way to enable the Clinical Research to analyze data for efficacy,...first site ready. + Remove obstacles and enable the Global Clinical Trial Organization to focus on… more
- ThermoFisher Scientific (Allentown, PA)
- …that people and communities depend on - now and in the future. Our global Clinical Operations colleagues within our PPD(R) clinical research services ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...letters in a timely manner using approved business writing standards . Escalates observed deficiencies and issues to clinical… more
- Merck (West Point, PA)
- …Vaccines and Advanced Biotechnologies (VAX) Process R&D in Development Sciences & Clinical Supply (DSCS) is responsible for the development and clinical ... the Process R&D organization, which enables modality-agnostic DS process development and clinical manufacturing for all of our company's pipeline. We are seeking an… more
- ThermoFisher Scientific (Allentown, PA)
- …+ Ability to understand and articulate complex scientific literature and use extensive complex clinical data as a key factor in the sales process + Medical ... Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day… 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
- Olympus Corporation of the Americas (Center Valley, PA)
- …our core values by staying **True to Life.** **Job Description** Olympus Global Internal Audit team comprises 60-70 auditors incorporating skills in finance, ... internal controls, SOX, IT, Compliance, operations, data analytics, non-financial metrics, and business consulting. Our ambition is to be a world class Internal… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and our core values by staying **True to Life.** **Job Description** The Olympus Global Ship Hold Center (GSHC) is dedicated to managing the end-to-end process and ... centralizing decision-making authority, ensuring consistency, and utilizing a dedicated tool to enhance global visibility. The role of a Quality Analyst - Global … 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
- 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
- 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, (2) effective deliverable development utilizing global and TA standards that optimize analysis and reporting and… 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
- Pfizer (Collegeville, PA)
- …studies, and submissions. + Comply with all statistics and quality processes, Pfizer data standards that are applicable to statistical outputs, and support ... Health Technology Assessment (HTA) submissions; and projects to maximize the value of aggregate clinical and real world data in support of drug development and… more
