Job Title: Global Clinical Study Director
About the Role:
The Senior Manager Clinical Study Lead plays a pivotal role in the execution of large and complex clinical trials. As a key member of our team, you will oversee the global delivery of assigned studies from design through execution to close out.
Responsibilities:
* Lead cross-functional study teams responsible for clinical study delivery and serve as primary point of contact for leadership and oversight (as required) for assigned studies.
* Oversee development of study-specific documentation, including case report forms, data management plans, monitoring plans, and more.
* Ensure compliance with clinical trial registry requirements and identify outsourcing needs of the study.
* Provide input into baseline budget development and management, as well as timeline development and management.
* Assess and mitigate risks at the study level, lead feasibility assessments, and select relevant regions and countries for the study.
* Conduct site evaluations and selections, prepare and execute investigator meetings, and monitor progress for site activation and monitoring visits.
* Develop and implement patient recruitment and retention strategies, monitor data entry and query resolution, and escalate issues related to study conduct, quality, timelines, or budget.
* Oversee the execution of the clinical study against planned timelines, deliverables, and budget, ensuring data quality and regular review of metrics and listings.
* Manage and oversee study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability.
* Contribute to clinical study report writing and review, facilitate lessons learned, and assign tasks to Clinical Study Management staff.
* Promote continuous improvement of CTM SOPs and participate in cross-functional and departmental process improvement initiatives.