Manager, Clinical Research Affairs

Job Title: Manager, Clinical Research Affairs Role Level: People Manager Supervisor/Manager Title: Director, Clinical Affairs Job Location & Environment: Irvine, CA – Corporate office environment Job Description Summary: The CRA Manager is a hybrid leadership role responsible for both direct line management of Site Managers (in-house CRAs) and execution of high-level site management activities across clinical trials. This individual plays a critical role in ensuring data quality, regulatory compliance, and operational excellence across investigational sites, while developing and leading a team of Site Managers. This role operates approximately 50% in people management and 50% in study/site oversight, acting as a key liaison between clinical operations, sites, and cross-functional stakeholders. This role is responsible for managing external vendors, including the CRO and any regional monitors or consultants supporting site management activities. The CRA Manager will oversee CRO performance against contracted deliverables, escalate performance gaps, and ensure CRO monitoring activities align with the sponsor’s quality standards and study objectives. This role plays a critical part in driving site activation, enrollment performance, and overall study execution. Job Responsibilities • Site Management & Clinical Operations (~50%) • Oversee site management activities across assigned clinical trials to ensure compliance with protocols, GCP, and regulatory requirements, applying risk-based monitoring (RBM) principles consistent with ISO 14155:2020 and ICH E6(R3). • Perform high-level data review and trend analysis to ensure data integrity, query resolution, and timely database readiness. • Serve as a senior point of contact for investigational sites, supporting complex issue resolution and relationship management. • Provide oversight of Trial Master File (TMF) quality and completeness, ensuring inspection readiness at all times. • Support and participate in site selection, initiation, monitoring strategy, and close-out activities as needed. • Lead or support audits and inspections, including preparation, documentation review, and response coordination. • Ensure IRB/EC approvals, renewals, and regulatory documentation are current and compliant. • Contribute to development and delivery of EDC and protocol training to sites and internal teams. • Partner cross-functionally (Clinical, Regulatory, Data Management, Quality, Medical Affairs) to ensure alignment and study success. • Oversee CRO and external vendor performance related to site management activities, including review of monitoring visit reports, tracking of key performance indicators, and escalation of performance gaps; contribute to vendor selection, qualification, and ongoing oversight planning. • People Management & Leadership (~50%) • Directly manage a team of currently ~4 Site Managers (in-house CRAs), with accountability for all aspects of the employment lifecycle: structured onboarding, role-specific training, ongoing performance management, corrective action where needed, and individualized career development planning. Anticipated to grow as the clinical portfolio expands. • Set measurable performance expectations; conduct regular 1:1s, formal mid-year and annual performance reviews, and individual development planning; recognize high performance and address underperformance in a timely and documented manner. • Ensure consistent execution of site management processes across the team, driving standardization and best practices. • Act as an escalation point for site-related issues and provide strategic guidance to Site Managers. • Assess resource needs across studies; plan and balance workload allocation across the Site Manager team; partner with Clinical Affairs leadership to identify staffing gaps, support hiring decisions, and scale the team as the portfolio grows. • Foster a collaborative, high-performance team culture aligned with company values. • Travel up to 25%, including domestic site visits, investigator meetings, and team oversight activities Qualifications Required Education and Experience: • Bachelor’s degree in Life Sciences, Nursing, or a related scientific discipline required. • Minimum of 5 years of clinical research experience, preferably within the medical device industry. • Minimum of 5 years of experience with clinical trial activities, including feasibility, start-up, study conduct, monitoring oversight, close-out, data review, and reporting activities. • Experience using CTMS, EDC, eTMF, and other clinical trial systems required. • Prior experience in a formal supervisory or people management role preferred (e.g., Lead CRA, CRA Team Lead, or direct management of clinical operations staff). Skills And Abilities Required For This Job • Strong working knowledge of the FDA regulatory framework, including experience supporting submissions such as IDE, PMA, and 510(k) (preferred). • In-depth understanding of Good Clinical Practice (GCP) and applicable regulations, including ISO 14155, ICH Guidelines, and relevant medical device directives/regulations. • Demonstrated experience developing and implementing Standard Operating Procedures (SOPs), clinical workflows, and operational metrics/trackers. • Proven ability to manage and oversee clinical sites, including startup, activation, enrollment support, and ongoing site performance. • Demonstrated people management skills, including the ability to set clear direction, deliver candid feedback, manage performance across a range of competency levels, and develop staff over time; experience supervising CRAs or clinical site management staff strongly preferred. • Ability to work collaboratively within a cross-functional medical device team, including Clinical, Regulatory, Data Management, Safety, and external vendors. • Strong organizational and project management skills, with the ability to prioritize, multi-task, and deliver high-quality work in a fast-paced environment. • Excellent written and verbal communication skills, with the ability to effectively present information, provide clear direction, and engage with investigators and site staff. • Demonstrated ability to identify risks, proactively problem-solve, and escalate appropriately to ensure study timelines and objectives are met. • Self-motivated, detail-oriented, and able to work both independently and within a highly interdependent team structure. Physical Requirements • Standard office environment requirements. • Travel, up to 25%.