Job Title: Senior Clinical Study Manager

Job Description

The Senior Clinical Study Manager is responsible for the delivery and execution of clinical studies across multiple geographic regions, adhering to Good Clinical Practices, Standard Operating Procedures, FDA regulations, and International Conference on Harmonization guidelines. This role involves routine interaction with both internal and external stakeholders, ensuring effective communication of project status and troubleshooting inquiries.

Responsibilities

• Lead the development of the clinical study plan, including critical path activities and interdependencies for assigned clinical studies.
• Create and manage the cross-functional Clinical Study Oversight Plan, ensuring adherence by the study team and coordinating activities with CROs and vendors.
• Provide operational input into study protocol profiles, final protocols, and amendments.
• Coordinate document review and medical writing tasks, including ICF, CRF guidelines, IB, and safety communications.
• Oversee the CRO and vendor selection process, including the creation of scopes of work and trial feasibility activities.
• Monitor clinical trial performance and quality metrics, ensuring issues are addressed and risks are mitigated.
• Manage study budget, including monitoring against trial progress and approving vendor invoices.
• Ensure compliance with quality measures and adherence to scope of work within timelines and budget at a task level.
• Coordinate operational activities for study start-up, interim analysis, database lock, and study close-out activities.
• Support department in codifying knowledge and best practices, preparing training, and making recommendations for improvement.

Essential Skills

• Expert level written and verbal communication skills.
• Strong decision-making abilities and clinical project management skills.
• Minimum of 7 years experience in Pharma/biotech.
• Experience in clinical trial study start-up and enrollment boosting activities.
• Experience overseeing CROs and vendor management.
• Proficiency in SharePoint, Excel, and PowerPoint.
• Experience working with IRT systems and global recruitment requirements.
• Recent experience in phase III oncology start-up, minimum 2 years.

Additional Skills & Qualifications

• Bachelor's degree in Science or advanced degree.
• Experience in clinical operations leading phase II or III global studies.
• Prior experience working for a Japanese company is a plus.
• Experience working as a CRA is a plus.
• Solid Tumor experience preferred, lung experience is beneficial.

Work Environment

This is a 100% remote role for candidates in the Eastern timezone or local to the NJ/PA/NY area. The position requires flexibility for face-to-face meetings.