- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile ... Title Clinical Research Regulatory Specialist B Job Description Summary The...-CC to participate in the coordination of Phase I-V clinical trials . Reporting to the Regulatory… more
- University of Pennsylvania (Philadelphia, PA)
- …of unit research, including but not limited to Phase I-IV clinical trials . The Regulatory Affairs Specialist C will, independently prepare and ... documentation/ Trial Master files (TMF) as required. The Regulatory Affairs Specialist C is expected to...but not limited to Phase I-IV clinical trials . The Regulatory Affairs Specialist … more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The** **Position** The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in ... vendors. The CTM will also assist to manage the clinical study team and help to coordinate meetings and...defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site… more
- Sumitomo Pharma (Harrisburg, PA)
- …International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to ... our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be...ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure… more
- Parexel (Harrisburg, PA)
- …or related industry experience + Previous experience of working in a Start-up team, as a Clinical Trial Specialist , or similar role, having worked on global ... and Regulatory Lead to enable a rapid clinical trial start up. + Inform team...clinical trials . + Experience of in-house trials /process design… more
- Bausch + Lomb (Harrisburg, PA)
- …plans, ensuring alignment with global requirements. + Provide guidance on risk assessment, clinical trial design implications, and regulatory pathways. + ... optimizing business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical ,… more
- University of Pennsylvania (Philadelphia, PA)
- …+ Experience in the following areas preferred: + Com pliance oversight for clinical trials ; monitoring or auditing of studies + Development of protocols, ... programs and resources, and much more. Posted Job Title Clinical Research Quality Specialist B (Department of...OCR Units to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives… more
- Merck (Harrisburg, PA)
- …sound processes, procedures, and strategies for ensuring data integrity in our clinical trials . **Primary Responsibilities:** + Leads their own specific tasks ... Business Processes, Clinical Documentation, Clinical Quality Management, Clinical Systems Implementation, Clinical Trials , Continual Improvement… more
- University of Pennsylvania (Philadelphia, PA)
- …Director for Regulatory Affairs will facilitate ongoing improvement of clinical trial compliance and quality assurance through communication of audit ... mentor any reporting Regulatory Affairs Supervisor and/or Regulatory Affairs Specialist A/B/C. In this capacity,...Cooperative/ Clinical Network Groups in the conduct of clinical trials . They will oversee preparations for… more
- University of Pennsylvania (Philadelphia, PA)
- …A Job Description Summary As part of the Department of Medicine, the DOM Clinical Trials Unit supports a diverse group of investigators, involving work on ... a wide spectrum of clinical trials ranging from phase I to...as: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions.… more