Manager of Clinical Affairs

Job Description

Job Description

About Renata Medical

Renata Medical is a fast-paced startup focused on developing and commercializing novel pediatric medical devices for children with congenital heart disease. We are passionate about delivering innovative solutions that improve the lives of our patients and their families. Join our mission-driven team and help us bring pediatric interventional cardiology life-changing products from concept to reality.

Position Overview

We are seeking a motivated and experienced Manager of Clinical Affairs to take ownership of designing, managing, and maintaining and consistent, repeatable system for clinical trial execution, and monitoring across Renata’s full clinical trial portfolio. This individual will build the operational backbone that allows Renata’s trials to run predictably as the portfolio grows, working cross-functionally with Regulatory Affairs, Quality, and the Chief Medical Officer.

This role requires a hands-on individual who thrives in a dynamic startup environment, collaborates cross-functionally, and is passionate about building robust, scalable clinical trial processes.

Key Responsibilities

• Build and own a standardized, repeatable playbook for trial design, site selection, activation, and execution across all Renata trials 
• Support protocol and trial design development for upcoming EFS and IDE studies in collaboration with the CMO and Regulatory Affairs 
• Establish consistent processes and documentation standards that scale as the trial portfolio grows 
• Serve as Renata's primary point of contact for the Clinical Research Organizations (CROs) supporting each active and upcoming trial 
• Manage day-to-day CRO performance, holding the CRO accountable to deliverables, timelines, and contracted scope 
• Review CRO monitoring visit reports and site-level metrics, and escalate performance or quality issues as needed 
• Own CRO budgets, contracts, and scope or change-order management 
• Coordinate between the CRO and internal teams (Regulatory Affairs, Quality, CMO) to keep programs aligned 
• Lead site selection and activation activities in partnership with the CRO 
• Monitor ongoing trials, including the Minima commercial trial and post-approval study, to ensure execution against protocol and timeline 
• Track program status and risk across all trials, surfacing issues early and driving them to resolution before they escalate 
• Ensure sites enroll as planned and trials start and progress on schedule 
• Coordinate and review clinical trial data to ensure it is decision-ready for internal and regulatory use 
• Manage reporting timelines and deliverables, including FDA reporting, publications, and conference abstracts 
• Maintain clear, proactive internal communication on program status, risks, and decisions across cross-functional teams 
• Provide case support and gather physician feedback as needed to inform product, regulatory, and quality teams
• Support input into IFU, usability, and procedural documentation as it relates to active trials

Qualifications

• Bachelor's degree in life sciences, clinical research, or a related field 
• 4+ years of experience in clinical trial management, ideally within Class II or III medical devices 
• Extensive experience managing CROs, including budget, scope, and performance oversight, across multi-site clinical trials 
• Working knowledge of FDA regulations, Good Clinical Practice (GCP), and IDE/EFS study requirements 
• Strong organizational and project management skills, with the ability to build systems and processes from the ground up 
• Excellent written and verbal communication skills 
• High attention to detail 
• Experience with pediatric or congenital heart disease (CHD) clinical trials preferred
• Experience supporting post-approval studies (PAS) a plus
• CCRP, CCRA, or similar clinical research certification preferred
• Experience scaling a clinical trial function withing a growing medical device company a plus

Benefits

• Full benefits package, including 401(k) and voluntary benefits
• Competitive compensation, including bonuses and equity
• Fast-paced start up culture with opportunities for career advancement