Clinical Study Manager

Position Overview: We are seeking a highly skilled and motivated Clinical Study Manager with expertise in respiratory medicine to lead the planning, execution, and management of clinical trials within our organization. The ideal candidate will have a strong background in clinical research, a thorough understanding of respiratory diseases, and demonstrated experience in overseeing all aspects of clinical trial operations.

Responsibilities:

• Collaborate with cross-functional teams to develop comprehensive study protocols and clinical development plans for respiratory-related trials.
• Contribute to the selection of appropriate study sites and investigators based on expertise and patient population.
• Oversee the day-to-day operations of clinical trials, ensuring adherence to protocols, regulatory requirements, and timelines.
• Manage study budgets, resources, and vendors to optimize trial efficiency and cost-effectiveness.
• Coordinate with clinical research associates (CRAs) to monitor site activities and ensure data quality and integrity.
• Ensure compliance with regulatory standards, including FDA, EMA, and other relevant authorities, throughout the conduct of clinical trials.
• Prepare and submit regulatory documents, such as Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs), as required.
• Identify potential risks and develop mitigation strategies to minimize their impact on trial progress and data integrity.
• Proactively address issues and deviations to maintain study timelines and objectives.
• Collaborate with biostatisticians and data management teams to analyze study data and interpret results.
• Prepare and review clinical study reports, regulatory submissions, and presentations for internal and external stakeholders.
• Work closely with medical affairs, regulatory affairs, pharmacovigilance, and other departments to align clinical development activities with overall corporate goals.
• Provide clinical expertise and guidance to support the development of new therapeutic interventions and product strategies.

Qualifications:

• Bachelor's degree in life sciences, pharmacy, nursing, or related field (advanced degree preferred).
• Minimum of 5 years of experience in clinical research, with a focus on respiratory diseases within the pharmaceutical or biotech industry.
• Proven track record of successfully managing multiple clinical trials simultaneously, from planning to closeout.
• In-depth knowledge of regulatory requirements and guidelines governing clinical research (FDA, EMA, ICH, etc.).
• Strong leadership, communication, and problem-solving skills, with the ability to collaborate effectively in a cross-functional team environment.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS) preferred.
• Certification in clinical research (e.g., CCRA, CCRP) is a plus.