- 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 ... your future at Takeda. Join us an Associate 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 ... best of my knowledge. **Job Description** Key to Takeda's success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and… 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
- 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 (Brighton, MA)
- …support the research teams 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 (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)
- …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
- Beth Israel Lahey Health (Burlington, MA)
- …clarifying material or missing material. + Works cooperatively with sponsor to ensure that good clinical practice are being followed. + Resolves data queries ... just taking a job, you're making a difference in people's lives.** The Clinical Research Coordinator will be responsible for the coordination and administration of… 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