Clinical Site Manager

We are searching for a Clinical Site Manager (CSM), who will play a pivotal role in orchestrating the operational aspects of clinical trials for a groundbreaking thrombectomy medical device. Your mission will be to manage these trials with precision and care, ensuring they adhere to the highest regulatory standards.

As a Clinical Site Manager, you will forge strong partnerships with investigational sites and physicians, spearhead patient recruitment initiatives, oversee protocol adherence, and steer these clinical studies toward success.

Please note: This person should be located in the Northeast area of the Unites States, New Jersey and New York are most desirable. This is a remote position and candidates should expect at least 80% travel.

Requirements of the Clinical Site Manager:

• A Bachelor’s degree in a relevant scientific or healthcare discipline (an advanced degree is a plus).

• At least two years of experience in clinical research, specifically related to cardiac medical devices or direct clinical experience in thrombectomy or cath lab environments.

• An in-depth understanding of pulmonary embolism thrombectomy procedures, cath lab operations, and the technologies utilized in catheterization.

• Familiarity with clinical trial processes, regulatory frameworks (like FDA, EU MDR), and adherence to Good Clinical Practice (GCP) standards preferred.

• Skilled in document analysis and interpretation, including reports, SOPs, and related materials.

• Exceptional communication, organization, and problem-solving abilities.

• The capacity to work autonomously, manage priorities across multiple projects, and meet deadlines.

• Willingness to travel up to 80% to fulfill job responsibilities.

Responsibilities of the Clinical Site Manager:

• Offer hands-on support and expertise at clinical trial sites, ensuring efficient enrollment and study progression.

• Lead and energize enrollment activities at study sites to achieve recruitment goals.

• Smoothly coordinate study activities with clinical sites from enrollment to completion.

• Guarantee study conduct aligns with regulatory standards, guidelines, and company policies.

• Engage with site staff and Investigators, providing necessary training and clarity on study requirements.

• Tackle and resolve site challenges and discrepancies promptly.

• Manage device logistics, including allocation, reconciliation, and retrieval, ensuring study integrity.

• Contribute to the reporting and resolution of device events and complaints.

• Guide your work with SOPs to ensure consistent, quality study management.

• Actively participate in professional development opportunities to expand your knowledge and expertise in the field.

Occupational Category: 19-1040 Medical Scientists