Position:
Clinical Trial Lead (CTL)
About Our client:
Our client is a pioneering organization at the forefront of developing
novel therapeutic strategies in the realm of neurological health. With a focus on cell-based treatment advancements, they are seeking a dedicated and proactive individual to join their dynamic team in a crucial role that contributes to groundbreaking scientific endeavors.
The Role
The CTL is pivotal in providing operational oversight and strategic
guidance for clinical site monitoring across ongoing research trials. This individual will act as the primary point of contact for clinical monitoring within the project team, ensuring that all activities align with the company's high standards and regulatory requirements.
The Job Description
Key Responsibilities:
The chosen candidate will lead and direct the Clinical Research Associates (CRAs) to manage the clinical trial sites efficiently, ensuring adherence to the study protocol and regulatory compliance. This role involves active participation from initial study setup through to completion, including monitoring plan development, training, and data review.
Requirements:
Leadership and management of CRAs for assigned clinical studies. Development and oversight of clinical monitoring plans and tools. Ensuring compliance with study-specific training and standard operating procedures.
Reviewing and tracking of site performance metrics and protocol adherence. Proactive identification and resolution of site issues, including development of corrective actions.
Maintaining continuous communication with the contract research organization (CRO) for consistent study execution.
Coordinating with internal and external stakeholders to maintain study quality and integrity.
Working Conditions:
This position is a remote role.
A degree of flexibility is balanced with necessary travel to fulfill monitoring and oversight duties. Expect once a month.
