The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Participate as the primary data management representative on the QED multidisciplinary project teams and as the primary point of contact for all data management interactions with the Sponsor. Participate in protocol developments and review, in review of clinical study reports and statistical analysis plan, in the development of data dictionaries complete with variables, value specifications and coding standards, and in monitoring the quality of data management processes, data, and performance. Review and provide inputs to CRF design and CRF Completion Instructions, database design, data management/data validation plans, data entry guidelines, and revisions to the Standard Operating Procedures. Manage resource planning methodologies and project management to ensure study deliverables and timelines are met in collaboration with the Sponsor, the Sponsor change order process, and to ensure effective communication exchange between the multidisciplinary project teams. Assist/Work with Sr. Management in identifying, developing, and implementing processes to improve/enhance time and cost efficiencies, to provide current information and potential impact of changes on project deliverables and timelines, to identify trouble-shoot issues and provide proposed solutions for problem resolution, to evaluate future potential data management solutions (e.g. functional service provider models, EDC systems) and prepare a business plan, to individual development, training, knowledge, and expertise through research, technical bulletins, and attending appropriate seminars, and to endorse and convey QED's corporate mission statement. Qualifications/Experience: - Bachelor's/Master's degree in computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution. - Minimum of 5 years of data management experience. - Project management experience is required. - Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required. - Direct management of employees within Clinical Data Management is preferred.,
The primary function of the Executive - Clinical Development is to plan and conduct clinical trials for QED. You will be responsible for producing clinical trial documents such as protocols, investigator brochures, study manuals, and monitoring plans. Your job responsibilities will include managing clinical trial sites by performing routine monitoring visits to ensure that the trial is carried out in accordance with the GCP guidelines, company SOPs, and currently approved protocol/amendment(s). You will also be responsible for monitoring the progress of the project, ensuring enrollment targets are met, and protecting the rights and well-being of human subjects. Additionally, you will need to ensure that reported trial data is accurate, complete, and verifiable from source documents. You will be required to recruit Investigators and negotiate budgets for participation in clinical trials. You will review and obtain draft protocols for completeness and feasibility, as well as regulatory and administrative documents from the trial sites for completeness. In this role, you will develop Case Report Forms, source document templates, and regulatory templates for the conduct of the clinical trial. You will also prepare and process (Serious) adverse event reports, project status reports for management, clinical study reports at the end of the study, and presentations for Investigator meetings. Participation in company required training programmes is essential. Approximately 40% of the time, overnight travel may be required. To qualify for this position, you should have an M.Pharm./MBBS/BDS/PhD (Life Sciences) degree and two (2) years of direct work experience in clinical trial monitoring, including site management. Experience should include actual on-site monitoring of clinical trials, PSSVs, site closeout visits, and conducting feasibility studies. Outstanding communication skills (both verbal and written) are a must to be successful in this role. Demonstrated expertise in using Microsoft Office products for presentations, documentations, and spreadsheets is essential.,