Senior Clinical Trials Manager

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Oversee, design, and execute all clinical operational elements of IVD clinical trials from the beginning to the conclusion.

• Act as the primary liaison for both internal and external study stakeholders; effectively communicating, collaborating, managing issue escalations when necessary, and participating in as well as leading internal and external study meetings.

• Identify, assess, and manage the qualification and contracting processes for study investigators, study sites, CROs, and/or vendor management relevant to the study.

• Develop or assist in creating study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans, and engagement materials.

• Ensure the trial master file (TMF/eTMF) is established, up-to-date, and maintained according to ICH E6 standards.

• Support and supervise the study-related tasks of Clinical Research Associates (CRAs) to ensure effective site training and management.

• Manage study deliverables and monitor study metrics, including identifying potential risks to study timelines and/or conduct.

• Review, suggest modifications, and approve monitoring trip reports for studies.

• Engage in data management activities, such as CRF development, training, and facilitating query resolution.

• Lead or contribute to the development, improvement, and implementation of organizational and departmental processes.

• Provide mentorship and guidance to junior team members.

⛳️ Requirements

• A Bachelor's degree or higher, or equivalent qualifications.

• Understanding of GCP, ICH guidelines, and other clinical regulatory standards.

• Excellent interpersonal skills (both verbal and written), as well as strong organizational and prioritization abilities.

• Capability to work autonomously and effectively in a fast-paced environment.

• Strong work ethic with the ability to complete tasks on schedule.

• Proficiency with office automation tools, particularly Microsoft PowerPoint, Excel, and Word.

• For Sr CTM: A minimum of 5 years of clinical study management experience within sponsor, CRO, companion diagnostics, device manufacturing, IVD, or similar industries, demonstrating effective and successful study management from initiation through to close-out.

• Experience in line management of CRAs and CTMs is preferred.

🏝️ Benefits

• Bonus

• Stock options

• Health insurance

• Paid time off

• Remote work options