Clinical Operations Manager

SiteBridge Research Inc Founded in 2021, SiteBridge Research is an integrated research organization, focused on building a national network of small and community medical practices to deliver world-class industry sponsored clinical research studies on time and on budget, accelerating time to completing clinical trials, accelerating time to market and product adoption in communities that are often underrepresented and difficult to reach. SiteBridge Research extends reach further into these communities to empower patients with some of the highest unmet needs to take part in clinical studies to improve inclusivity in clinical research and to improve overall health outcomes. Job Description: The Clinical Operations Manager is an experienced clinical research professional who provides oversight and support to Clinical Research Coordinators (CRCs) and site staff across multiple sites or satellite locations within our site network. This role requires in-depth industry understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. The Operations Manager is responsible for site oversight, including study readiness, CRC and site performance, and overall site performance against key performance metrics for each assigned study. The Operations Manager maintains a staffing plan for the resourcing and utilization of site operations team members across multiple locations or larger sites to achieve performance objectives, identify opportunities or gaps, and implement plans accordingly. This role also supports study start-up, maintenance, and close-out activities, and partners cross-functionally with recruitment, budget, and finance teams to drive site success. In addition, and most importantly, this role represents the SiteBridge Research mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will maintain the operational excellence required of clinical sites/staff involved in clinical studies and ensure ICH/GCP and SOP compliance. The person in this role will report to the Executive Director of Site Operations. The position is remote with up to 30% travel at time during peak study activities for candidates with prerequisite experience. 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 portfolioOwn site and CRC performance against key performance metrics for each assigned study, identifying gaps early and implementing corrective action plansDrive accountability for patient enrollment, ensuring sites own the enrollment plan to meet recruitment goals for their specific studiesResponsible for CRC hiring, onboarding, training, performance management, and retention across all assigned sites and satellite locationsSupport project start-up, maintenance, and close-out activities across assigned sites, including study start-up and close-out, recruitment, and regulatory submissionsIdentify barriers to timely study activation, efficient coordination, and site performance, and partner with appropriate teams to identify and implement solutionsPartner cross-functionally with recruitment, budget, and finance teams to drive site success and support forecasting and financial performance at the site levelAs necessary, step in and fill site and study level needs including but not limited to site set-up and CRC duties to meet SiteBridge and sponsor needsEvaluate and communicate metrics of all activity related to assigned sites and studies, and provide summary findings and recommendations to leadershipTrack study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policiesPrepare, participate in, and follow-up on audits/inspections as needed, including direction for audit prep and any required follow up post auditParticipates in required training and education programsParticipate in meetings (ie., Investigator Meetings, Site Trainings, Conferences) and seminars to update knowledge of clinical research and related issues as necessaryOther duties and support as assigned related to site and study operationsTravel is required (up to 30%) for projects related to site development and 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 basisMinimum 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 requiredBilingual, Spanish speaking candidates are encouraged to applyProven success overseeing performance across multiple sites or locations within an organizationDemonstrated 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 requiredExperience with eSource, eRegulatory, and CTMS is requiredExperience in study document preparation (CRF, eSource, logs, SOPs, etc.) is a plusStrong preference for experience within multiple phase research and therapeutic areasExperience 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 deadlinesDetail-oriented and meticulous in all aspects of workSuperior interpersonal, organization, and management skillsCapable of working independently with minimal supervisionUnderstanding of medical terminology as well as standard clinical procedures and protocols Additional Qualifications Strong project and time management skillsHigh level of collaboration, customer orientation awareness and focusSkilled with standard computer programs including the MS Office suiteStrong interpersonal, written, and verbal communication skills Additional Information SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance. JOB CODE: 26-0014