Freelance clinical research consultant
freelance
Total des années d'expérience :14 years, 7 Mois
• Designing and writing clinical trials protocols
• Writing statistical analysis plan and performing statistical analysis for clinical trials using various softwares (SPSS, SAS, STATA, R)
• Responding to the regulatory authorities’ queries and questions regarding clinical trials files submission.
• Training clinical trial team on writing clinical trial study protocols and analysing study results.
• Designing clinical trials particularly bioequivalence studies
• Supervising trial protocol writing
• Ensuring trial’s compliance with Good Clinical Practice (GCP) principles.
• Following up trial approvals with the local authority and ethics committee, and responding to their queries
• Direct communication with external sponsors and responding to issues related to trial conduction progress and results
• Creating timelines for various projects and making the arrangements to make sure that the all deadlines are fulfilled assuring the completeness and accuracy of the job.
• Participating in budgeting of clinical trials
• Performing statistical & pharmacokinetic analysis and interpreting the clinical
trials results using statistical software (SAS, STATA & WinNonlin)
• Supervising writing of the trial final reports.
• Designing clinical trials particularly bioequivalence studies
• Supervising trial protocol writing
• Ensuring trial’s compliance with Good Clinical Practice (GCP) principles.
• Following up trial approvals with the local authority and ethics committee, and responding to their queries
• Direct communication with external sponsors and responding to issues related to trial conduction progress and results
• Creating timelines for various projects and making the arrangements to make sure that the all deadlines are fulfilled assuring the completeness and accuracy of the job.
• Participating in budgeting of clinical trials
• Performing pharmacokinetic analysis and interpreting the bioequivalence trials results using WinNonlin
• Supervising writing of the trial final reports.
• Compliance with local and international regulations for human subject research and
clinical trials.
• Follow and implement in-house policies and procedures for clinical trial conduct.
• Review and commentary to clinical trial agreements.
• Organize, facilitate and coordinate clinical trials particularly phase II and III clinical
• Organising appointments and meetings with community- and hospital-based healthcare staff
• Presenting products to healthcare staff including doctors, nurses and pharmacists
• Attending and organising trade exhibitions, conferences and meetings
• Reviewing sales performance
• Participated in setting the sales target plan
• Worked on a study of pricing change and its effect on drugs sales.
• Organising appointments and meetings with community- and hospital-based healthcare
staff
• Presenting products to healthcare staff including doctors, nurses and pharmacists
• Attending and organising trade exhibitions, conferences and meetings
• Reviewing sales performance
• Participated in setting the sales target plan
• Worked on a study of pricing change and its effect on drugs sales.
• Evaluate the key methodologies used in applied health research, taking into account quantitative, qualitative and mixed methods approaches • Formulate clear health research questions and hypotheses and evaluate which methodologies are most appropriate to undertake them • Undertake quantitative analyses of health related data, using the most appropriate analytic methods such as linear regression, logistic regression, survival analysis, etc and software packages like SPSS and STATA. • Formulate, plan, undertake a research in an area related to applied heath, taking into account ethical considerations
• Understanding drug design and the development of drug products • Detection, extraction, isolation and quantitative/qualitative analysis of drugs • Studying pharmacokinetics properties of the drugs by understanding absorption, distribution, metabolism and excretion processes.