Senior Site Manager - Cross Therapeutic Area

Benefits

Qualifications

• •Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific discipline is required
• •Minimum 2 years of clinical trial monitoring experience required
• •Knowledge of the drug development process, Good Clinical Practices (GCPs) and FDA CFR required
• •Strong working knowledge of GCPs, SOPs, local laws and regulations, and protocol-specific procedures including monitoring guidelines is required
• •Proficient computer skills and experience with clinical systems required
• •Excellent written and verbal communication skills
• •Willingness to travel up to 75% with overnight stays required
• •Valid driver’s license issued in the United States and a good driving record required
• •Required Skills: Clinical Trial Operations, Execution Focus, Time Management, Study Management, Regulatory Environment, Regulatory Inspections, Project Support, Proactive Behavior, Problem Solving, Process Improvements, Mentorship, Laboratory Operations, Business English, Clinical Data Management, Research and Development, Research Ethics
• •6 more items(s)

Responsibilities

• •Serve as the primary contact point between the Sponsor and the Investigational Site for assigned trials
• •Ensure inspection readiness and compliance with the clinical trial protocol, SOPs, Good Clinical Practice (GCP), and applicable regulations from study start-up through site closure
• •Assist with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring, and close-out activities
• •Collaborate with Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Trial Delivery Leader (TDL) to manage sites for assigned protocols
• •May contribute to process improvements, training and mentoring of other Site Managers
• •Operate independently with minimal supervision
• •Act as local company contact for assigned sites and participate in site feasibility and Site Qualification Visits (SQVs)
• •Attend investigator meetings and assist with meeting materials and presentations as needed
• •Perform site initiation, monitoring (including remote monitoring), site management and site/study close-out in accordance with SOPs and policies; implement risk-based monitoring at the site level and resolve issues promptly
• •Ensure site staff training and training records are complete and accurate; collaborate during site activation to expedite activation
• •Support site recruitment strategies and contingency planning in partnership with other functional areas
• •Ensure adequate study supplies (e.g., Non-Investigational Product, lab kits) for trial conduct and proper handling of clinical drug supplies, with proper inventory and destruction where applicable
• •Oversee data entry accuracy, query resolution, data integrity, and essential document management in relevant systems
• •Proactively report Adverse Events (AEs)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) within required timelines and ensure consistency with source data
• •Maintain complete trial records and communicate status and issues to stakeholders; document monitoring activities and write visit reports and follow-up letters per SOPs
• •Review study files for completeness and retention; coordinate with LTM to document site progress and issues to the trial central team
• •Participate in regular team meetings and trainings; comply with training requirements and maintain therapeutic knowledge to support the role
• •Work with LTM on CAPA for QA site audits and quality issues; may oversee audit and inspection preparation for junior staff
• •Prepare trial sites for close out and conduct final close-out visit; track site-level costs and ensure payments if applicable
• •Build and maintain good relationships with investigators, trial coordinators and other site staff; may participate in HA/IEC/IRB submissions as required
• •Act as a site management specialist and may be assigned as a coach or mentor; contribute to process improvements and training; may lead special initiatives and act as Subject Matter Expert as assigned
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