Analyzes clinical trial protocols and studies, ensuring adherence to regulatory requirements and alignment with strategic objectives, providing recommendations for protocol optimization and enhancement, working independently.
Collaborates with multidisciplinary teams to develop robust clinical development strategies for New Product Introduction (NPI) projects and post-market initiatives, integrating inputs from stakeholders such as Marketing/BU Claims, regional/market needs, and Post Market Surveillance (PMS). Crafts comprehensive and compliant Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing expert-level proficiency in standard software tools and systems, adhering to internal procedures, templates, and external standards, regulations, and guidance. Troubleshoots complex issues related to clinical data collection, analysis, and reporting, leveraging advanced analytical skills to ensure data integrity, accuracy, and consistency across studies. Assesses and critically analyzes clinical study data within the clinical study report, synthesizing findings to support dissemination efforts such as abstracts, white papers, and peer-reviewed publications, contributing to the advancement of scientific knowledge. Communicates effectively with internal and external stakeholders, ensuring clarity and alignment on project objectives, milestones, and timelines, facilitating informed decision-making and fostering collaborative relationships. Facilitates interactions with colleagues to determine and implement optimal approaches for evidence generation and clinical study design, fostering a culture of innovation and excellence within the clinical development team. Presents findings from literature reviews and data analyses to internal stakeholders, contributing to informed decision-making processes and strategic discussions. Builds relationships with Key Opinion Leaders (KOLs) and Investigators (particularly in China), facilitating the execution of clinical studies and ensuring robust data generation, contributing to the credibility and success of clinical development programs. Disseminates evidence derived from clinical studies, effectively communicating the impact and significance of findings to internal teams and external stakeholders, contributing to the broader scientific community and market understanding. Facilitates ongoing collaboration and interaction between internal teams, fostering a culture of cross-functional teamwork and knowledge sharing to drive project success.