Manager, Clinical Research Affairs

Overview

The CRA Manager is a hybrid leadership role responsible for both direct line management of Site Managers (in-house CRAs) and high-level site management activities across clinical trials. This role focuses on data quality, regulatory compliance, and operational excellence across investigational sites, while leading a team of Site Managers. It operates approximately 50% in people management and 50% in study/site oversight, serving as a key liaison between clinical operations, sites, and cross-functional stakeholders. The CRA Manager oversees external vendors, including CROs and regional monitors or consultants supporting site management activities, and ensures CRO performance aligns with sponsor quality standards and study objectives. This role contributes to site activation, enrollment performance, and overall study execution.

Responsibilities

• Site Management & Clinical Operations (~50%): Oversee site management activities across assigned trials to ensure compliance with protocols, GCP, and regulatory requirements, applying 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 with Clinical, Regulatory, Data Management, Quality, and 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 KPIs, and escalation of performance gaps; contribute to vendor selection, qualification, and ongoing oversight planning.

People Management & Leadership

• Directly manage a team of currently ~4 Site Managers (in-house CRAs), with accountability for all aspects of the employment lifecycle: onboarding, role-specific training, performance management, corrective action, and individualized career development planning. Anticipated to grow with portfolio expansion.
• Set measurable performance expectations; conduct regular 1:1s, formal mid-year and annual performance reviews, and development planning; recognize high performance and address underperformance in a timely and documented manner.
• Ensure consistent execution of site management processes, 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 workload allocation; 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.
• 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.
• Experience using CTMS, EDC, eTMF, and other clinical trial systems.
• PQrior 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

• Strong working knowledge of the FDA regulatory framework, including IDE, PMA, and 510(k) (preferred).
• In-depth understanding of GCP and applicable regulations, including ISO 14155, ICH Guidelines, and medical device directives/regulations.
• Experience developing and implementing SOPs, clinical workflows, and operational metrics/trackers.
• Proven ability to manage and oversee clinical sites, including startup, activation, enrollment support, and ongoing site performance.
• People management skills: setting clear direction, providing candid feedback, managing performance, and developing staff; experience supervising CRAs or clinical site management staff preferred.
• Ability to work across cross-functional teams (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 for presenting information and engaging with investigators and site staff.
• Ability to identify risks, proactively problem-solve, and escalate to meet timelines and objectives.
• Self-motivated, detail-oriented, and able to work independently and within a team.

Physical Requirements

Standard office environment requirements. Travel, up to 25%.