Responsible for developing strategy based on regulatory requirements. Serve as a liaison between regulatory and other functional areas. Act as Local Contact Person for Pharmacovigilance for the designated country.
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As a Study Management Associate II, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team. The Study Management Associate II works as a contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of a Study Project Manager and SMA Manager. The Study Management Associate II works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives.
The primary objective for our Medical Director/Senior Medical Sciences is to provide input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training.
The Senior Clinical Trial Manager (CTM) oversees the planning, execution, and completion of clinical trials to ensure they meet regulatory standards, timelines, and budget constraints. This role is pivotal in ensuring the integrity and success of clinical research studies.