Candidates must possess a Bachelor's or advanced degree in life sciences, nursing, or a related field, with a minimum of 7 years of experience in clinical trial management within biotech, pharmaceutical industry, or a CRO. Essential skills include excellent leadership, team management, communication (written and verbal), interpersonal, organizational, multitasking, project management, analytical, problem-solving, and decision-making abilities, along with meticulous attention to detail and a strong focus on data integrity. Proficiency with clinical trial management systems (CTMS), Electronic Data Capture (EDC) systems, and standard MS Office software is required, as is a strong understanding of regulatory submission processes and global regulatory requirements. Previous experience as a Clinical Research Associate (CRA) and demonstrated experience with Phase 1-2 trials are preferred.
The Senior Clinical Trial Manager will lead global, multi-phase clinical trials from initiation through closeout, overseeing vendors and CROs to ensure compliance with GCP and regulatory guidelines, and maintaining trial quality, timelines, and budget. Key duties include developing and implementing operational plans, coordinating all trial-related activities such as site selection and patient recruitment, managing study timelines and budget, conducting progress meetings, ensuring adherence to GCP and regulatory requirements, overseeing trial document creation and maintenance, participating in Health Authority inspections and audits, serving as the primary contact between sponsor, investigators, sites, and functional teams, providing regular study updates to management, and managing external vendor performance. The role involves cross-functional collaboration and up to 25% travel for site visits and trial oversight.
Develops therapies for autoimmune diseases
Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.