Associate Site Manager – Cross Therapeutic Area

Responsibilities

• Serve as the primary contact point between the Sponsor and the Investigational Site.
• Ensure inspection readiness of trial sites by complying with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines.
• Assist with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on‑site and remote monitoring, and close‑out activities.
• Partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Trial Delivery Leader (TDL) for overall site management while performing trial‑related activities.
• Execute activities within site initiation and start‑up, preparation and conduct of site monitoring (including remote monitoring), site management and site/study close‑out according to SOPs, Work Instructions (WIs) and policies.
• Implement an analytical risk‑based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits.
• Ensure site staff are trained, and the corresponding training records are complete and accurate at any point during all trial phases.
• Collaborate closely with LTM and the central study team for activities during the site activation phase.
• Ensure site study supplies are adequate for trial conduct.
• Ensure clinical drug supplies are appropriately used, handled and stored, and returns are accurately inventoried and documented.
• Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management.

Requirements

• A bachelor's degree in pharmacy, nursing, life sciences, or a related scientific discipline.
• At least one year of clinical trial monitoring experience.
• Experience with Phase II and Phase III clinical trials is preferred.
• Basic working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol‑specific procedures, including monitoring guidelines.
• Strong computer skills in appropriate software applications and related clinical systems.
• Strong written and oral communication skills.
• Willingness to travel up to 60% with overnight stays away from home.
• A valid driver’s license issued in one of the 50 United States and a good driving record.
• Clinical research certification is preferred.