Clinical Trials Quality Specialist

2 weeks ago

alappuzha, India beBeeAudit Full time

Job Title: Quality Assurance AuditorA Quality Assurance Auditor is a vital role in ensuring the quality and integrity of clinical trials.The ideal candidate will have extensive experience in auditing, with a strong understanding of GCP, ICH guidelines, and FDA/EMA regulations. They will be responsible for conducting site audits, reviewing documentation, and verifying adherence to protocols and regulatory requirements.Key Responsibilities:Conduct thorough audits of clinical research sites across phases I–IV, identifying areas for improvement and implementing corrective actions as needed.Review CRFs, informed consent forms, and regulatory documents to ensure compliance and accuracy.Provide expert guidance and training to site staff on compliance and quality management practices.Analyze audit findings and develop effective solutions to address any issues or concerns.Prepare comprehensive audit reports, including recommendations for improvement, and follow up on CAPA implementation.Requirements:Bachelor's degree in life sciences, nursing, pharmacy, or related field.No less than 10 years of clinical research experience, with significant auditing and QA experience.Strong knowledge of GCP, ICH guidelines, and FDA/EMA regulations.Excellent communication, analytical, and organizational skills, with the ability to travel as required.Preferred Qualifications:Clinical Research or Quality Auditing certification (ACRP, SOCRA).Experience working with eTMF and EDC systems.Proven track record of auditing multi-center or global trials.

  • Expert Clinical Trials Specialist

    4 days ago

    alappuzha, India beBeeEDC Full time

    Clinical Trial Setup ExpertThis role focuses on creating electronic Case Report Form (eCRF) specifications, designing and developing clinical trial setup processes. Responsibilities include implementing User Acceptance Test (UAT) scripts to validate the setup of the clinical study, managing blinded and unblinded study configurations, and integrating other...

  • Clinical Trials Quality Manager

    2 weeks ago

    alappuzha, India beBeeAudit Full time

    Quality Assurance AuditorThe Quality Assurance Auditor is responsible for ensuring compliance and quality at clinical trial sites. This includes conducting site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP, and regulatory requirements.Conduct audits of clinical research sites across phases I–IV.Review CRFs, informed...

  • Advanced Data Analyst

    2 weeks ago

    alappuzha, India beBeeStatistical Full time

    Job Description:We are seeking a highly skilled and experienced Senior Statistical Programmer to join our team. As a key member of our organization, you will be responsible for performing data manipulation, analysis, and reporting of clinical trial data.Responsibilities:Perform data manipulation, analysis, and reporting of clinical trial data using advanced...

  • Senior Technical Lead

    2 weeks ago

    alappuzha, India beBeeTechnical Full time

    Technical Leadership RoleWe are seeking a seasoned technical lead to drive statistical programming activities in Oncology clinical trials. As a senior expert, you will be responsible for developing and maintaining SDTM/ADaM datasets, TLFs (Tables, Listings & Figures), and submission-ready outputs.Develop, validate, and maintain datasets according to CDISC...

  • Data Science Specialist for Clinical Development

    2 weeks ago

    alappuzha, India beBeeRegulatory Full time

    Job Title: Statistical Programmer LeadJob Overview:We are seeking a highly skilled Statistical Programmer Lead to join our team. As a key member of our clinical development team, you will be responsible for designing and implementing statistical programming strategies to support the analysis and interpretation of clinical trial data.Key...

  • Clinical Study Programming Lead

    1 week ago

    alappuzha, India beBeeStatistical Full time

    Job Title:A leading statistical programmer is required to oversee programming activities for clinical studies and ensure timely delivery of high-quality results.This role involves working independently, collaborating with internal stakeholders and external partners to implement project standards and deliverables.Key Responsibilities:Lead programming...

  • Lead Programmer

    2 weeks ago

    alappuzha, India beBeeStatisticalProgramming Full time

    As a Statistical Programming Lead, you will be responsible for spearheading statistical programming activities for various studies and projects.Key Responsibilities:Develop and maintain programming documentations following industry standards and best practices.Create CDISC standard SDTM mapping specifications and ADaM specifications.Develop and oversee the...

  • Clinical AI Development Specialist

    2 weeks ago

    alappuzha, India beBeeExpertise Full time

    Medical AI Training SpecialistThis is a remote and flexible role that utilizes your clinical expertise to enhance the performance of artificial intelligence (AI) in diagnostic and reasoning tasks.Key Responsibilities:Develop and answer complex clinical questions to train AI models in diagnostic and reasoning tasks.Review and analyze AI-generated responses...

  • Programmer Expertise Sought

    5 days ago

    alappuzha, India beBeeData Full time

    Senior Programmer Job DescriptionWe are seeking a highly skilled Senior Programmer to enhance our global R codebase for generating CDISC ADaM datasets and tables, listings, and figures in accordance with clinical trial data requirements.Develop and maintain global R codebase for generating CDISC ADaM datasets and tables, listings, and figures in accordance...

  • Advanced Data Analyst Position

    2 weeks ago

    alappuzha, India beBeeDataAnalysis Full time

    We are seeking an experienced Statistical Analyst to join our team in a role that requires strong analytical skills and expertise in statistical programming.The ideal candidate will have hands-on experience with statistical analysis and reporting in clinical trials, proficiency in SAS and R for statistical modelling, efficacy analysis, and data...