Role Overview: As a Specialist in the laboratory, your main responsibility will be to perform laboratory procedures and experiments. You will need to communicate any problems and progress to your supervisor effectively. It will also be your duty to select appropriate experimental and analytical methods, define protocols, and schedule your tasks in accordance with assignments and priorities. In case of deviations in results or potential problems, you may need to recommend modifications in protocols under the supervision of your supervisor. Key Responsibilities: - Perform laboratory procedures and experiments - Communicate problems and progress to supervisor - Select appropriate experimental and analytical methods, define protocols - Schedule tasks and activities according to assignments and priorities - Detect deviations in results and/or potential problems, recommend modifications in protocols - Write laboratory procedures under supervisor's approval - Compile experimental data, perform calculations, and prepare graphs for presentation - Write research papers, reports, reviews, and technical summaries - Monitor laboratory notebook for accurate data recording - Capable of performing all duties required of a Specialist Qualifications Required: - Bachelor's degree in a relevant field (e.g., Chemistry, Biology) - Previous experience working in a laboratory setting - Strong analytical and problem-solving skills - Excellent written and verbal communication skills (Note: Additional Company Details section omitted as it was not present in the provided job description),
As a Clinical Study Manager, you will be responsible for developing clinical study designs, writing study protocols, and monitoring plans. You will play a crucial role in training the study team on relevant aspects of clinical studies and ensuring the proper execution of statistical and data management plans. Your key responsibilities will include: - Developing clinical study design - Writing clinical study protocols - Writing study monitoring plan - Training study team on relevant parts of clinical studies - Ensuring statistical plan and data management plan are properly performed - Ensuring study risk analysis plan is properly executed - Designing CRFs (case report forms) and ensuring they are well completed and collected - Preparing documentation for EC/IRB submission and following up during the study - Conducting site initiation visits for training site personnel on protocol, study procedures, and regulatory requirements - Monitoring the study throughout its duration - Performing study close-out activities - Managing clinical databases and data analysis - Preparing final clinical study reports - Ensuring compliance with GCP and ethical/regulatory frameworks - Preparing study documentation for regulatory submissions Your role will also involve internal networking with R&D, Regulatory Affairs, Design Quality, and Operations colleagues. (Note: No additional details about the company were provided in the job description),