- Boston University (Boston, MA)
- …options. This person will organize, maintain and develop current and new educational offerings on Good Clinical Practice ( GCP ) and proper conduct of ... working with small and large groups of people. + Demonstrated knowledge of clinical /human research conduct, GCP , Federal regulations guiding human research (21… more
- IQVIA (Boston, MA)
- …of, and skill in applying applicable clinical research regulatory requirements; ie, Good Clinical Practice ( GCP ) and International Conference on ... **PURPOSE** Clinical Leadership is focused on the delivery and...and the relevant environments in which it operates + Good understanding of the competitive environment and how to… more
- Sanofi Group (Cambridge, MA)
- …2 studies + Assure successful execution of the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as ... **Senior Clinical Research Director, Early Development** **About the Job**...recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a… more
- Randstad US (Norwood, MA)
- …on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice ( GCP ), internal SOPs and regulations and White ... laboratory skills: SOP, Assay Development, Assay Method, Assay Verification, GLP ( Good Laboratory Practice ), Laboratory Information Management Systems (LIMS),… more
- J&J Family of Companies (Cambridge, MA)
- …study set-up, execution and analysis/reporting of phase 0, and Ph2a studies according to Good Clinical Practice ( GCP ), International Conference of ... entry to Proof-of-Concept (PoC). The role requires expertise in Gastroenterology Early Phase Clinical Development. The TM Leader will become part of the GI DAS… 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
- Merck (Boston, MA)
- …Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and ... policies. + Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for your specific… more
- Merck (Boston, MA)
- …Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and ... policies + Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) **Research** + Upon… 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
- Beth Israel Lahey Health (Boston, MA)
- …required in clinical trials and/or regulatory. 3. Solid understanding of FDA good clinical practice guidelines 4. Ability to maintain confidential and ... 40 **Work Shift:** Day (United States of America) The Clinical Trials Monitor (CTM) monitors and audits the investigator-initiated...of research quality. (essential) + Competent in ICH E6 ( GCP /GLP/GCLP), ICH Q9, 21 CFR, GDPR and, HIPAA laws… more
- Caris Life Sciences (Boston, MA)
- …documents, pre- and post-approval. + Socialize regulatory requirements and clinical practice guidelines (eg, FDA CFR, ICH GCP , ISO20916, ISO14971, ISO13485, ... clinical validation programs with focused attention on Design Controls and Good Clinical Practices for clinical performance studies. The Sr. Director will… more