- Merck (West Point, PA)
- **Job Description** **Position Description:** **Manager, Operations and Reference Data Management, Global Clinical Data Standards ** Working closely ... with the Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data Management within the Global Data Management & … more
- Merck (North Wales, PA)
- …our existing and pipeline products to produce safe, effective, innovative medicine. The Global Clinical Data Standards Vocabulary Specialist, Associate ... Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical...Vocabulary Specialist may lead or participate in:** + Internal clinical data standards forums +… 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
- 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
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Specialist, Clinical Operations** Global Clinical Trial Operations (GCTO) is a global organization ... of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and...team player and ability to work independently in a global setting Microsoft Office and data analytics… 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)
- …in the delivery of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. The Regional ... Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical...team player and ability to work independently in a global setting. + Microsoft Office and data … more
- J&J Family of Companies (West Chester, PA)
- …of all evidence generated, including abstracts, manuscripts, CSRs, and use of clinical data /evidence for market access and reimbursement. Draft study reports ... systems, primarily Metadata Rave, is _preferred_ . * Experience working with and analyzing clinical data sets _strongly preferred_ . * Proven track record of… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards . + Lead or assist with identifying ... associated follow-up activities (eg, reports, corrective actions). + Perform reviews of clinical study documentation for data integrity and compliance with GCP… 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
- Teleflex (Wayne, PA)
- …approved product information, samples, educational materials, professional guidelines and standards related to best practices, and clinical evidence-based ... Surgical Clinical Affairs Manager **Date:** May 6, 2024 **Location:**...**Requisition ID** :10303 **About Teleflex Incorporated** Teleflex is a global provider of clinically effective medical technologies designed to… more
- Merck (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... Teams. Lead and provide statistical support for related drug/vaccine projects in Clinical Safety Statistics + Interact with Safety Physicians, Safety Scientists, … 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)
- …professionally communicate both verbally and in writing in English. Can discuss clinical data succinctly and accurately with cross-functional lines, scientific ... with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data . + Basic understanding of the drug development process.… more
- Pfizer (Collegeville, PA)
- …groups, relevant policy, standards development organizations & applicable global data standards , situational leadership, site-based epidemiology, ... Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature as well as building...activities by sharing best practices, approaches and applicable common data models / data standards ,… 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
- 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)
- …and other project stakeholders. **Primary Activities:** + Programmatically synthesize preclinical / clinical data into analysis ready structures from varied ... Specific Required Skills and Experience:** + Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH +… more
- System One (Blue Bell, PA)
- …with pediatric, in-patient / hospital-based studies, highly desired + Experience monitoring global clinical trials for a product through all clinical ... COVID-19 vaccination required + Minimum of at least 3-4 years of Onsite Clinical Monitoring experience. At least 1-year additional experience in related field +… more