About the job
Join Our Team as a Senior Study Manager!
As a Senior Study Manager at US Tech Solutions, you will play a pivotal role in overseeing complex Phase I and extended Phase I/II oncology clinical trials. You will be responsible for managing all aspects of these clinical studies, ensuring strict adherence to Bayer's standards, Good Clinical Practices (GCP), and all applicable regulatory requirements.
Your primary responsibilities will include:
- Leading and managing cross-functional teams throughout the study lifecycle, from initial concept through to the final Clinical Study Report (CSR).
- Overseeing all study-related activities and providing critical input to the Operational Sub-team to ensure accurate tracking of study execution.
- Developing and managing study budgets, timelines, and quality deliverables, while proactively addressing any budgetary concerns.
- Coordinating study start-up activities, including CRO selection, CRF development, and recruitment planning.
- Collaborating with team members to write protocols and amendments, ensuring feasibility and site selection meet enrollment timelines.
Your mission is to drive the planning, implementation, analysis, and reporting of clinical pharmacology studies, all while ensuring high-quality data and meeting global regulatory approval criteria. We are looking for someone who is proactive and seeks opportunities for global process improvement.
