- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and overseeing the ... platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio...regulatory requirements. The Director will manage a team of Clinical Trial Managers (CTMs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good … more
- Insmed Incorporated (San Diego, CA)
- …appropriate review of all safety data from various sources (eg pre- clinical , clinical trial data, post-marketing, literature) throughout the development ... to the PV scientists on decisions that have significant drug safety implications, including safety ...and applicable ICH guidelines is strongly desired. Experience in drug development, clinical trial methodology;… more
- Merck & Co. (North Wales, PA)
- …or related field and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life ... or related field and at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal skills and ability to… more
- Merck & Co. (North Wales, PA)
- …or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... related field plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal… more
- Genmab (Plainsboro, NJ)
- …Oversee early-stage programs and develop clinical programs including component studies. Oversee safety of the drug , including the safety aspects of ... Lead creation and review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (ie,… more
- Merck & Co. (North Wales, PA)
- …3 years of experience with all of the following: SAS programming in a clinical trial environment; developing analysis and reporting deliverables for Research and ... statistical analysis and high-quality data to support decision making in clinical trials.Support statistical programming activities for late-stage drug /vaccine … more
- BioAgilytix (Boston, MA)
- …lab at BioAgilytix Boston. In this role, you'll perform high-complexity patient and clinical trial testing under CLIA while ensuring specimen integrity through ... never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain...strict adherence to quality and safety procedures. This is a great opportunity to gain… more
- General Dynamics Information Technology (Frederick, MD)
- …Citizenship Required:** Yes **Job Description:** **GDIT's Military Health team is hiring a Clinical Trial Manager to support the Office of Regulated Activities ... procedures manual, study specific procedures, pharmacy manual, FDA Form 1572, clinical trial agreement(s), and transfer of regulatory obligations documentation… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Summary** This Director, Medical Evidence Generation (MEG) Clinical Trial Physician (CTP) - Cell Therapy (CT) role ... MD required (or x-US equivalent) plus 2-3 years of clinical trial experience, either in industry or...experience, either in industry or academic setting; expertise in drug development process and clinical research; experience… more
- Bristol Myers Squibb (Cambridge, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Trial Physician sits within Clinical Development, which is ... of expertise in key Health Authority interactions and advisory board meetings as Senior Clinical Trial Physician + Authors/drafts clinical content for CSRs,… more
- AbbVie (North Chicago, IL)
- …with 2+ years patient care experience strongly preferred + Minimum 2 years' experience in drug safety or a related discipline in the pharmaceutical industry + ... Trial Designs, Immunology is to support the overarching safety strategy for innovative study design concept and execution...Clinical trial experience strongly preferred + Excellent clinical … more
- University of Utah (Salt Lake City, UT)
- …provides education to ensure patients understand their treatment options in relation to a clinical trial , as well as potential benefits or risks of their ... nurses, and research teams to identify and assess potential clinical trial candidates. + Review medical records,...the successful completion of a criminal background check and/or drug screen. The University of Utah values candidates who… more
- Mount Sinai Health System (New York, NY)
- … protocols and charters. + Provides reports and statistics related to dissemination of safety information to the Clinical Trial Management team members and ... part of the research study team and monitors all safety aspects of clinical research trial...+ Participates in or is responsible for reconciliation of drug safety databases and clinical … more
- Lilly (Indianapolis, IN)
- …Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases. Specific activities include ... reporting of adverse events as mandated by corporate patient safety ; review process for protocols, study reports, publications and...new product development activities over the entire spectrum of drug development and clinical trial … more
- Sumitomo Pharma (Columbus, OH)
- …rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality, patient safety , and compliance with GCP standards. ... to the end of the product's life cycle. + Clinical Trial Oversight: Develop and oversee ...clinical and medical expertise across all stages of drug development, from preclinical transition to post-marketing. + Stay… more
- Lilly (Indianapolis, IN)
- …protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study ... this role is responsible for all aspects of global clinical trial operations within the plan, as...upward + Partner with regulatory and medical to ensure safety management and monitoring processes are implemented **Communication and… more
- University of Pennsylvania (Philadelphia, PA)
- …vigilance in patient safety , protocol compliance and data quality. + Communicate clinical trial patient activity to the investigational drug pharmacy ... research performed. He/she will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject… more
- Walgreens (Deerfield, IL)
- …techniques. This role ensures the safety , rights, and well being of clinical trial participants, the integrity of study data, and the compliance of ... essential documents across all Walgreens clinical trial site services. The position is... drug /device development process, including experience with new clinical trial models such as decentralized/hybrid trials.… more
