Site Engagement Manager

Job Description :

We are seeking a motivated and highly organized Site Engagement Manager to join our clinical operations team at a fast-growing biotech company.

This role will be responsible for building and maintaining strong relationships with clinical trial sites, ensuring the efficient and timely execution of clinical trials.

The ideal candidate will have experience working in clinical operations or site management, with a focus on driving site performance and improving patient recruitment and retention.

Fluency in Spanish is a plus as this role will involve managing sites with diverse patient populations.

Key Responsibilities :

• Site Relationship Management : Serve as the primary point of contact for clinical trial sites, fostering strong, collaborative relationships with investigators, site staff, and other stakeholders.
• Site Activation & Start-Up : Oversee and manage the site selection process, initiation activities, and timely site activation to ensure that sites are ready for patient enrollment.
• Site Monitoring & Performance : Monitor site performance throughout the lifecycle of the clinical trial. Ensure that sites adhere to study protocols, timelines, and regulatory requirements.

Address issues and challenges proactively to ensure sites meet enrollment and quality targets.

Patient Recruitment & Retention : Collaborate with site staff to develop and implement strategies aimed at improving patient recruitment, enrollment, and retention.

Ensure that sites have the necessary tools and support to optimize patient engagement and compliance.

Training & Support : Provide ongoing training and support to site staff, ensuring they have a clear understanding of the protocol, study procedures, and regulatory requirements.

Serve as a resource for resolving operational challenges at the site level.

Problem-Solving & Issue Resolution : Proactively identify and address any site-level issues, including patient enrollment barriers, compliance concerns, or operational inefficiencies.

Work with internal teams to develop and implement solutions to keep the study on track.

Collaboration with Cross-Functional Teams : Work closely with Clinical Operations, Regulatory Affairs, Data Management, and other internal teams to ensure seamless communication and coordination with sites.

Provide regular updates to management on site performance and study progress.

Documentation & Reporting : Ensure accurate and timely documentation of site activities in accordance with Good Clinical Practice (GCP) and company standards.

Prepare and submit regular reports on site progress and performance metrics.

Required Qualifications :

• Experience : 3+ years of experience in clinical trial management, site engagement, or clinical operations within a biotech, pharmaceutical, or CRO environment.
• Strong Knowledge of Clinical Trials : Solid understanding of clinical trial processes, regulations (e.g., GCP, ICH), and the responsibilities of clinical trial sites.
• Communication Skills : Strong interpersonal and communication skills, with the ability to build relationships and communicate effectively with diverse site staff and stakeholders.
• Fluency in Spanish (Preferred) : Ability to speak, read, and write in Spanish is a plus, as this role will involve managing sites with Spanish-speaking patient populations.
• Problem-Solving Skills : Strong analytical and problem-solving skills to identify issues early and implement solutions to keep trials on track.
• Organizational Skills : Excellent organizational skills, with the ability to manage multiple sites, priorities, and timelines concurrently.
• Attention to Detail : Strong attention to detail and ability to maintain high-quality standards in site operations.

Preferred Qualifications :

• Experience working in a biotech or medical device environment.
• Knowledge of patient recruitment and retention strategies, particularly in underserved or diverse communities.
• Experience in managing international or multi-site clinical trials.
• Bachelor's degree in Life Sciences, Nursing, or a related field.
17 hours ago