- GE HealthCare (Boston, MA)
- **Job Description Summary** The Good Clinical Practice ( GCP ) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are ... + Training and Education: They may provide training to clinical trial personnel on GCP requirements, SOPs, and best practices to ensure understanding and… more
- Philips (Cambridge, MA)
- The Senior Good Clinical Practice ( GCP ) Auditor will play a critical role in ensuring Philips' Clinical Studies and practices are compliant with ... Internal/External regulatory and quality standards. **Your role:** + Executing & leading Good Clinical Practice ( GCP ) audits in line with defined… more
- 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 ... with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as well… more
- 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
- Children's Hospital Boston (Boston, MA)
- …+ Ensure that research activities completed by study staff are performed in compliance with Good Clinical Practice ( GCP ) and program standards. Ensures ... Research Manger will develop and oversee the implementation of best practice guidelines for conducting various clinical research protocols, collaborate with… more
- Philips (Cambridge, MA)
- …administration or a related field. + Your skills include a strong understanding of Good Clinical Practice ( GCP ) regulations and regulatory requirements ... ** Clinical Operations Manager - Clinical Data Intelligence** You will be responsible for Clinical Operations Management for research partnerships related 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** The Senior Clinical Research Director (Sr CRD) supports several early stage programs and manages a team… more
- Astrix Technology (Boston, MA)
- …including ophthalmic devices. * Strong understanding of clinical research regulations and Good Clinical Practice ( GCP ) guidelines. * Excellent ... Clinical Research Associate Clinical Data Management Boston, MA, US Pay Rate Low: 71.50 | Pay Rate High: 85.72 + Added - 13/05/2024 Apply for Job ** Clinical … more
- Medtronic (Boston, MA)
- …engineer) experience **Nice to Have** + Hospital/ clinical experience + Experience in Good Clinical Practice ( GCP ) and regulatory compliance ... Lives** In this exciting role as the Senior Field Clinical Research Specialist, you will be responsible for ...Clinical Research Specialist, you will be responsible for clinical trial site management, case coverage, and clinical… more
- Merck (Boston, MA)
- …closely with the Quality Assurance group and the Good Clinical Practice Quality and Compliance Council ( GCP QCC). + Represent GCTO and the country ... awareness of the International Conference on Harmonization Good Clinical Practice (ICH GCP ) and Global/Regional/Local regulatory requirements is needed.… more
- Pfizer (Cambridge, MA)
- …clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice ( GCP ), regulatory agencies, ... operations-type role with a proven track record executing clinical studies preferred. + Comprehensive knowledge of GCP... clinical studies preferred. + Comprehensive knowledge of GCP and ICH guidelines. + Good understanding… 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
- Merck (Cambridge, 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) for the Regional… more
- Insight Global (Boston, MA)
- …Organization (CRO) in compliance with the Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practice ( GCP ) and 21 Code of ... for issues presented by remote uploading stations, and data transmittal to DFCI Clinical Research Coordinators (CRC), clinical trial sponsors and Clinical … more
- Randstad US (Cambridge, MA)
- …and comfortable with shifting priorities and change in a small company environment skills: SOP, GCP ( Good Clinical Practice ), ICH Regulations, TMF Equal ... and ICH GCP guidelines to ensure the appropriate conduct of clinical studies + Good verbal and written communication skills + Good organizational skills… more
- Randstad US (Cambridge, MA)
- …+ Statistical, data management, and regulatory knowledge. skills: Pharmacology, Data Management Plan, GCP ( Good Clinical Practice ), ICH Regulations Equal ... pharmaceutical industry or CRO is required + Knowledge in ICH - GCP ( Good Clinical Practices) (International Conference on Harmonization). + Ph.D., or… more
- Merck (Boston, MA)
- …collaboration with other functions within and outside of GCTO to ensure that Good Clinical Practice Health Authority inspections are adequately supported ... that QCO are mentored and developed to lead/support regulatory GCP inspections. **In this role you will:** + **Lead...Collaborate with cross-functional teams to support and adequately manage Good Clinical Practice Health Authority… 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