Senior Clinical Trial Manager

Job Description: Senior Study Manager

We are seeking an experienced and highly skilled Senior Study Manager to join our clinical operations team. This position requires a minimum of 12-15 years of experience in clinical operations, with at least 7 years of specialized experience in global study management.

Responsibilities:

1. Lead and oversee the operational execution of global clinical trials, ensuring adherence to ICH/GCP guidelines, regulatory requirements, and internal standard operating procedures.
2. Collaborate closely with cross-functional teams, including clinical research associates, data management, biostatistics, and other stakeholders, to ensure seamless study conduct and timely delivery of high-quality data.
3. Develop and implement comprehensive study plans, risk management strategies, and contingency plans to mitigate potential risks and ensure successful study execution.
4. Monitor study progress, identify potential issues, and implement corrective actions as needed, ensuring timely resolution of any deviations or protocol violations.
5. Manage vendor selection, contracting, and oversight, ensuring effective collaboration and performance of external partners.
6. Participate in the development of study protocols, informed consent forms, and other essential study documents, providing operational input and expertise.
7. Contribute to the preparation and review of regulatory submissions, safety reports, and other documentation as required.
8. Represent the organization at investigator meetings, sponsor meetings, and other external events, fostering effective communication and collaboration with study stakeholders.

Qualifications:

1. A minimum of 12-15 years of experience in clinical operations, with at least 7 years of dedicated global study management experience.
2. Preference will be given to candidates with experience from Japanese biotech or pharmaceutical companies.
3. Strong understanding of ICH/GCP guidelines, regulatory requirements, and industry best practices in clinical trial management.
4. Proven track record of successfully leading and managing complex, global clinical trials across various therapeutic areas.
5. Excellent communication, collaboration, and interpersonal skills, with the ability to effectively interact with cross-functional teams, vendors, and external stakeholders.
6. Proficiency in project management, risk management, and problem-solving skills.
7. Strong organizational skills, attention to detail, and the ability to multitask and prioritize in a fast-paced environment.
8. Proficiency in relevant software applications and clinical trial management systems.
9. Bachelor's degree in a scientific or related field; advanced degree in a relevant discipline is preferred.
10. Willingness and ability to commute to our office in New Jersey, as this is a hybrid role.

We offer a competitive compensation package and an opportunity to be part of a dynamic and innovative team dedicated to advancing healthcare solutions. If you possess the required qualifications and are passionate about contributing to the success of global clinical trials, we encourage you to apply for this exciting opportunity.