Clinical Operations Manager

Responsibilities

• Provide day-to-day oversight of CRCs and site staff across multiple sites or satellite locations, ensuring study readiness, protocol compliance, and consistent execution across the portfolio
• Own site and CRC performance against key performance metrics for each assigned study, identifying gaps early and implementing corrective action plans
• Drive accountability for patient enrollment, ensuring sites own the enrollment plan to meet recruitment goals for their specific studies
• Support project start-up, maintenance, and close-out activities across assigned sites, including study start-up and close-out, recruitment, and regulatory submissions
• Identify barriers to timely study activation, efficient coordination, and site performance, and partner with appropriate teams to identify and implement solutions
• Partner cross-functionally with recruitment, budget, and finance teams to drive site success and support forecasting and financial performance at the site level
• Evaluate and communicate metrics of all activity related to assigned sites and studies, and provide summary findings and recommendations to leadership
• Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies
• Prepare, participate in, and follow-up on audits/inspections as needed, including direction for audit prep and any required follow up post audit
• Participates in required training and education programs
• Participate in meetings (ie., Investigator Meetings, Site Trainings, Conferences) and seminars to update knowledge of clinical research and related issues as necessary
• Other duties and support as assigned related to site and study operations

Qualifications/Required Experience

• Bachelor's degree minimum: a combination of education and related technical/professional experience may be substituted for the degree requirements and will be considered on a case-by-case basis
• Minimum of four (4) years of clinical research or related experience. Experience as a CRC, CRA, Site Lead, Site Manager, or related is required
• Minimum of 2 years of experience supervising or overseeing CRCs or site staff, including staffing and resource planning, is required
• Bilingual, Spanish speaking candidates are encouraged to apply
• Proven success overseeing performance across multiple sites or locations within an organization
• Demonstrated knowledge of clinical trial operations and execution related to but not limited to start-up, regulatory submission, site feasibility, ect.
• Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
• Experience with eSource, eRegulatory, and CTMS is required
• Experience in study document preparation (CRF, eSource, logs, SOPs, etc.) is a plus
• Strong preference for experience within multiple phase research and therapeutic areas
• Experience with necessary clinical study and staff records related to clinical study activity which includes case report forms, drug dispensation records, etc.
• Excellent communication skills, attention to detail, problem-solving, follow-through, and organizational skills, with the ability to multi-task and work under/meet deadlines
• Detail-oriented and meticulous in all aspects of work
• Superior interpersonal, organization, and management skills
• Capable of working independently with minimal supervision
• Understanding of medical terminology as well as standard clinical procedures and protocols