- 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)
- …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
- 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
- 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 & 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 (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
- 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)
- …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
- J&J Family of Companies (Spring House, PA)
- …and goals for J&J Drug development, to ensure diverse patient representation across global clinical trials. This role will liaise with other stakeholders across ... Global Development (GD) and the enterprise to communicate a...efforts * Develop, implement and enforce key 'Diversity in Clinical Trials' standards , processes and templates to… more
- Actalent (Philadelphia, PA)
- …Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP) standards , and study protocols related to data management activities. + ... plays a pivotal role in ensuring accurate and timely data management for clinical trials. This role...Experience Level: Expert Level About Actalent Actalent is a global leader in engineering and sciences services and talent… more
- IQVIA (Philadelphia, PA)
- …process and outcomes, clinical hiring targets and processes and onboarding and training standards . * Evaluate the quality of the clinical work product for ... related to corporate or departmental strategic plans. Provide leadership for clinical operations marketing and global sales activities. **Qualifications** *… more
- ThermoFisher Scientific (Philadelphia, 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
- Penn Medicine (Philadelphia, PA)
- …available on site as needed to liaise with the patient, representatives, and clinical service teams. Many global patients require interpreter services. Global ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… 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
- 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
- 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
