- Sanofi Group (Cambridge, MA)
- …plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as ... you thought was possible. Ready to get started? This Clinical Research Director (CRD) role in Early Neuro-Development is...recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a… more
- Takeda Pharmaceuticals (Boston, MA)
- …operational procurement experience with a solid working knowledge of category management and ICH E6 R2 Good Clinical Practice " GCP " and/or ICH Q7 Good ... my knowledge. **Job Description** **OBJECTIVES** **:** The Global Category Manager: Clinical Supplies & Comparators ( Clinical Development Services Procurement)… more
- Schrodinger (Cambridge, MA)
- …clinical trials are conducted in accordance with all relevant regulations and guidelines, including Good Clinical Practice ( GCP ) + Contribute to ... Therapeutics Group is seeking a physician-scientist to serve as a **Vice President, Clinical Research** working on novel oncology compounds in the early stages of… more
- IQVIA (Boston, MA)
- …close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference ... skill in applying, applicable clinical research regulatory requirements (ie, Good Clinical Practice ( GCP ) and International Conference on… more
- Dana-Farber Cancer Institute (Boston, MA)
- …overseeing and managing regulatory inquiries regarding protocol development, human subject protections, Good Clinical Practice ( GCP ) guidelines, and ... Affairs Specialist (RAS) positions are critical to successfully achieving ongoing clinical research expansion and regulatory compliance at DFCI. **The selected… more
- IQVIA (Boston, MA)
- …team + In-depth knowledge of applicable clinical research regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on ... of R programming as well as SAS(R) Base, and good knowledge of SAS(R) graph and SAS(R) Macros. +...+ Excellent application development skills. + Strong understanding of clinical trial data and extremely hands on in data… more
- IQVIA (Boston, MA)
- …close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference ... the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …by a vendor, as needed. + Adhere to SOPs for computer system validation and all GCP ( Good Clinical Practice ) regulations. + Ensure compliance with own ... of your future at Takeda. Join us a Manager, Clinical Data Validation Engineer in our Cambridge, MA office....CDE teams to ensure adherence to Takeda standards and GCP principles. DVEs are vital to all data cleaning… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …by a vendor, as needed. + Adhere to SOPs for computer system validation and all GCP ( Good Clinical Practice ) regulations. + Ensure compliance with own ... of your future at Takeda. Join us as a Clinical Data Configuration Engineer in our Cambridge, MA office....+ Strong attention to detail, and organizational skills + Good time management skills + Quick learner and comfortable… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …by a vendor, as needed. + Adhere to SOPs for computer system validation and all GCP ( Good Clinical Practice ) regulations. + Ensure compliance with own ... best of my knowledge. **Job Description** Key to Takeda's success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and… more
- ThermoFisher Scientific (Cambridge, MA)
- …assurance or clinical trial auditing/monitoring, and/or good clinical practice . * Thorough knowledge of ICH GCP and FDA guidelines * Experience using ... (Days) **Environmental Conditions** Office **Job Description** SUMMARY OF POSITION The Clinical Data Monitor will be responsible for compliance monitoring across… more
- Randstad US (Cambridge, MA)
- …large complex data sets. skills: CDISC, Data Validation Plan, Clinical Data Management, GCP ( Good Clinical Practice ), EDC (Electronic Data Capture) ... [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the operational initiation/set-up, vendor and… more
- WuXi AppTec (Boston, MA)
- …and office-based monitoring and data quality control functions in accordance with Good Clinical Practices ( GCP ), International Conference on Harmonization ... these years being oncology-based monitoring experience. + Experience using Good Clinical Practices and a good...Must possess a thorough understanding of FDA Guidelines, ICH, GCP , NDA, IND, and other applicable regulations. + Ability… more
- Dana-Farber Cancer Institute (Boston, MA)
- …support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and ... and managing clinical research studies + Shows an understanding of ICH/ GCP and Federal Regulatory requirements + Shows an understanding of DF/HCC SOPs +… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …of clinical trials, including multi-center Principal Investigator (PI) initiated trails. Using Good Clinical Practice under the auspices of the Principal ... The Senior Clinical Research Coordinator work within the clinical...and II within the program + Articulates understanding of ICH/ GCP and Federal Regulatory requirements + Articulates understanding of… more
- Sanofi Group (Cambridge, MA)
- …and technical expertise** + Has and maintains deep scientific, technical and clinical expertise in respiratory/immunology field + Has a demonstrated track record in ... clinical development, preferably in industry, with Phase 3 experience...trials, ensures adherence to company standards and regulatory requirements ( GCP /ICH), and supports development of investigator brochures. + Leads… more
- Sanofi Group (Cambridge, MA)
- …an abbreviated and full clinical study protocol + Oversee the execution of clinical studies in compliance with internal SOPs, GCP , ICH guidelines and other ... you thought was possible. Ready to get started? The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic...recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a… more
- Sanofi Group (Cambridge, MA)
- …Brand Lead, nirsevimab Vaccines and you'll play a key leadership role in the clinical and commercial development of all products in the Franchise's portfolio. We are ... improve people's lives.** Our ambition is to **transform the practice of medicine** through breakthrough science and achieve a...Franchise and playing a key leadership role in the clinical and commercial development of all products in the… more