The Senior Clinical Trial Manager (Sr. CTM) is responsible for managing the clinical and operational activities of assigned clinical studies. This is accomplished by ensuring all projects are completed on-time and on-budget while following all company policies, Standard Operating Procedures (SOPs) and applicable regulatory guidelines. Plan, develop, and follow systems and procedures to ensure optimum compliance in accordance with GCP/ICH guidelines and FDA regulations. Ensure operating quality and efficiency.

Essential Duties and Responsibilities

• Support or lead clinical study activities from start-up through closeout, ensuring adherence to timelines, budget, quality standards, SOPs, and regulatory requirements.

• Oversee development and maintenance of study documentation including informed consent forms, IRB submissions, project plans, tracking tools, financial worksheets, and regulatory files.

• Engage with investigative sites during start-up to coordinate CDAs, feasibility assessments, budgets, and CTAs.

• Manage and maintain the Trial Master File (TMF), ensuring accuracy, completeness, and inspection readiness.

• Oversee monitoring activities, including review and approval of monitoring visit reports, tracking site issues, data queries, protocol deviations, and ensuring timely resolution.

• Assign, mentor, and support CRAs; lead team training, provide performance feedback, and ensure ongoing staff compliance with required training.

• Monitor enrollment trends, operational risks, and study metrics; develop mitigation strategies and escalate issues appropriately.

• Conduct internal team calls, participate in Sponsor meetings, and serve as key contact for site, CRA, and Sponsor inquiries.

• Coordinate clinical resource planning, monitoring schedules, and budget oversight related to monitoring activities; support PM with grant administration and invoicing.

• Participate in development/testing of clinical systems and process improvement initiatives.

• Perform co‑monitoring visits and, when needed, assume CRA responsibilities.

• Complete vendor reconciliation and support cross-functional collaboration to ensure data quality.

• May serve as a Line Manager.

• May serve as Program level oversight.

• Serves as Clinical representative for bid defenses.

• Participates in proposal development.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

• Supervisory experience

• Minimum 5 years’ experience in the clinical research industry

• Minimum of 2 years‘ experience as a Clinical Monitor/Clinical Research Associate (CRA) strongly preferred

• 2 years of Clinical Trial Management (CTM) experience, or an equivalent role to successfully perform the key responsibilities of the role.

• Experience working in CNS clinical trials strongly preferred

• Strong knowledge and application of clinical research process

• Advanced knowledge and understanding of ICH, GCP guidelines and other regulatory rules and guidelines

• Strong interpersonal and communication skills with the ability to work with all levels of management and employees, provide effective customer service, and foster positive working relationships with internal and external stakeholders

• Excellent communication skills, both oral and written

• Demonstrated ability to work effectively within a cross-functional team to meet objectives and deliverables; ability to be adaptable and achieve performance goals while navigating various competing demands, tight deadlines, and a fast-paced environment

• Strong organizational skills that reflect the ability to manage, prioritize, and perform multiple tasks seamlessly

• Strong computer skills, including proficiency in Microsoft Office, Electronic Data Capture, and other clinical systems

• Meticulous attention to detail

• Time management and ability to prioritize

• Ability to travel 10-20%