Senior Clinical Trials Site Lead

Dm Clinical Research Group; Bergen (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Dm Clinical Research Group is seeking a Site Manager to ensure high-quality research at assigned investigative sites in line with sponsor protocols, FDA regulations, and ICH-GCP guidelines. You will lead site staff, oversee training, and drive enrollment to meet sponsor expectations.

Responsibilities include coordinating training, ensuring visit preparedness, maintaining essential study documents, and facilitating sponsor/CRO interactions while ensuring compliance and data integrity across

Qualifications

• Bachelor’s degree preferred.
• Advanced degree preferred.
• At least 4 years of clinical research coordinator experience, including 2 years of management experience at a CRO.
• Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.
• Solid teamwork, organizational, interpersonal, and problem-solving skills.
• Knowledge of FDA regulations, ICH-GCP and ISO standards.
• Proficient English with bilingual English/Spanish preferred.

Responsibilities

• Ensure quality research at assigned sites in accordance with sponsor protocol, FDA regulations and ICH/GCP guidelines.
• Ensure study enrollment meets sponsor expectations and company goals on time.
• Supervise and develop site staff under Site Director/Director of Site Operations.
• Complete required training and maintain current certifications (ICH-GCP, IATA, protocol training).
• Prepare sites for sponsor/CRO visits and ensure timely follow-up on action items.
• Maintain up-to-date study documents (protocols, consent forms, study manuals).
• Manage clinical trial activities from first patient first visit to study close-out.

Skills

Teamwork

Organizational skills

Interpersonal skills

Problem solving

Critical thinking

Active listening

Reading comprehension

Communication skills

Multitasking

Time management

Bilingual EN/ES

Education

Bachelor’s degree preferred

Advanced degree preferred

Tools

Clinical systems

EDC / IVRS

MS Office

Job description

Dm Clinical Research Group is seeking a Site Manager to ensure high-quality research at assigned investigative sites in line with sponsor protocols, FDA regulations, and ICH-GCP guidelines. You will lead site staff, oversee training, and drive enrollment to meet sponsor expectations.

Responsibilities include coordinating training, ensuring visit preparedness, maintaining essential study documents, and facilitating sponsor/CRO interactions while ensuring compliance and data integrity across