Clinical Site Manager/CRA, Northeast (NY/NJ/MA)

Astellas - (Contractor) - New York, NY

Full-time - Mid Level

Hybrid - New York, NY

About the position

The Clinical Site Manager II (CSM II) serves as the primary contact between the Sponsor and Investigational Sites, ensuring compliance with clinical trial protocols and regulations. This role involves managing site relationships, supporting clinical trial delivery, and ensuring inspection readiness from study start-up to site closure. The CSM II collaborates with various clinical trial roles to facilitate effective site management and communication.

Responsibilities

• Act as the primary local company contact for assigned sites for specific trials.
• Develop meaningful site relationships through consistent communication and engagement.
• Participate in site feasibility and/or pre-trial site assessment visits.
• Attend investigator meetings as needed.
• Serve as Lead CSM for specific studies, providing oversight and support for other CSMs.
• Drive activities within site initiation and start-up, preparation, and conduct of site monitoring.
• Implement risk-based monitoring approaches at the site level and ensure timely resolution of issues.
• Ensure site staff are trained and maintain accurate training records.
• Collaborate with the study team to expedite site activation processes.
• Ensure site compliance with study protocol, ICH-GCP, and local regulations.
• Oversee site-level recruitment strategy and ensure adequate non-IMP study supplies.
• Ensure proper handling and storage of clinical drug supplies and oversee their destruction.
• Ensure timely data entry and resolution of queries by site staff.
• Maintain complete and accurate trial data and essential documents in relevant systems.
• Document trial-related activities and write visit reports according to SOPs.
• Communicate relevant status information and issues to stakeholders promptly.
• Review study files for completeness and ensure archiving requirements are met.
• Act as a local expert in assigned protocols and develop therapeutic knowledge to support responsibilities.
• Work closely with CTL to ensure CAPA is completed for QA site audits and quality issues.
• Prepare trial sites for close-out and conduct final close-out visits.
• Establish and maintain good working relationships with internal and external stakeholders.

Requirements

• Bachelor's degree in a relevant field or equivalent experience.
• Experience in clinical research or site management, preferably in a pharmaceutical or biotech environment.
• Strong understanding of clinical trial processes, regulations, and Good Clinical Practice (GCP).
• Excellent communication and interpersonal skills to build relationships with site staff and stakeholders.
• Ability to manage multiple sites and protocols effectively.
• Strong organizational skills and attention to detail.

Nice-to-haves

• Advanced degree in a relevant field (e.g., Master's, PhD).
• Experience with early and late-phase clinical trials.
• Knowledge of risk-based monitoring approaches.
• Experience in mentoring or training less experienced site managers.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Flexible scheduling options
• Professional development opportunities