At the forefront of innovation, we push boundaries to make a meaningful impact on people's lives. Our team leads clinical development activities in the US, Puerto Rico, and Canada, fostering collaboration and driving results.
The role entails overseeing site maintenance, contract amendments, records management, training, and trial metrics across therapeutic areas. As a key point of contact for Competent Authorities, you will support budget and contract negotiations, and manage regional responsibilities as needed.
Prioritizing, planning, and executing site maintenance activities with timely delivery aligned with portfolio needs is crucial. You will provide leadership and technical support to the North America Maintenance Team, ensuring inspection readiness by maintaining a complete and accurate Trial Master File.
Main Responsibilities:
* Maintain compliance with local/regional requirements, data privacy, and quality standards.
* Manage communications and relationships, representing trial capabilities to internal and external partners.
* Support global solutions and coordinate with other clinical development functions.
* Prioritize work to meet portfolio needs and ensure resource flexibility.
* Maintain expertise in clinical research and regional regulatory requirements.
* Develop strategies to enhance customer experience.
* Maintain inspection readiness with a complete Trial Master File.
Organizational Leadership:
* Foster shared learning within the team and across functional groups.
* Enhance capabilities through process, tool, and training development, leveraging technology.
* Cultivate a culture of continuous improvement and efficiency.
People Management and Development:
* Recruit, develop, and retain a skilled workforce.
* Manage an agile organization to adapt to changing needs.
* Foster an inclusive and innovative culture with sound decision-making.