Lead, Clinical Monitoring Services - Arizona

Who you are

You have a proven track record in clinical research management, with extensive experience leading teams of Clinical Research Associates. Your leadership style is collaborative, and you excel in providing guidance and support to your team members. You understand the importance of adhering to regulatory requirements and best practices in clinical research, ensuring that your team is well-trained and compliant with Celerion's policies. You are flexible and willing to travel to the Tempe, Arizona site for both planned and impromptu meetings, demonstrating your commitment to the role and the team.

You possess strong organizational skills, allowing you to effectively manage staff workloads and allocate resources efficiently. Your experience includes conducting feasibility studies, site qualification visits, and routine monitoring visits, ensuring that clinical trials are executed smoothly and effectively. You are adept at maintaining Trial Master Files and handling Serious Adverse Events (SAEs), showcasing your attention to detail and commitment to patient safety.

Your ability to communicate effectively with both internal and external stakeholders is one of your key strengths. You can articulate complex clinical research concepts clearly and concisely, fostering strong relationships with site staff and sponsors alike. You are passionate about advancing clinical research and are motivated by the impact your work has on bringing new therapies to market.

Desirable

Experience in a variety of therapeutic areas is a plus, as is familiarity with different types of clinical studies, including interventional and non-interventional trials. You may also have a background in regulatory affairs or quality assurance, further enhancing your ability to lead your team effectively.

What you'll do

In this role, you will oversee the monitoring and site management activities for clinical trials, ensuring that all studies are conducted in compliance with Celerion's Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) guidelines. You will provide direct supervision and line management for a team of Clinical Research Associates, guiding them through their daily responsibilities and supporting their professional development.

You will be responsible for interviewing, hiring, and onboarding new staff, ensuring they receive the necessary training and resources to succeed in their roles. Your leadership will be crucial in preparing and implementing function-specific training programs, fostering a culture of continuous learning and improvement within your team.

As a key member of the management team, you will liaise with the Manager of Monitoring to ensure optimal resource allocation and project assignments. You will monitor staff workloads and provide support as needed, ensuring that all clinical projects are adequately staffed and that timelines are met.

You will also play a vital role in maintaining compliance with regulatory requirements, conducting regular audits of clinical trial activities, and ensuring that all documentation is accurate and up-to-date. Your attention to detail will be essential in maintaining Trial Master Files and handling any Serious Adverse Events that may arise during the course of a study.

What we offer

Celerion offers a dynamic work environment where you can make a significant impact in the field of clinical research. You will have the opportunity to work with a talented team of professionals dedicated to advancing clinical trials and improving patient outcomes. We provide competitive compensation and benefits, along with opportunities for professional growth and development. Join us in our mission to bring innovative therapies to market faster and improve the lives of patients around the world.