Manager, Clinical Research Affairs

Job Responsibilities

• 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.

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.