Clinical Data Manager

We are changing the standard of care for millions of untreated sufferers of ENT conditions. We improve patient access to life-changing relief through safe, practical, and effective innovation that changes how and where patients are served. Aerin differentiates itself with our commitment to providing straightforward and clinically proven products so that ENTs and their patients can make treatment decisions together without limits.

At Aerin Medical our values show up as: always seeking the collective good, holding ourselves and each other accountable, showing respect with compassion, creation and innovation and being all in.

As the Clinical Data Manager, you will be an essential part of our mission-driven team, dedicated to transforming the lives of those with untreated ENT conditions. Your role will involve contributing directly to our commitment to innovation and improved patient care.

PURPOSE OF JOB: The Clinical Data Manager (CDM) will oversee the planning, coordination, and execution of clinical data management activities across multiple studies in compliance with regulatory standards, Good Clinical Practice (GCP), and internal Standard Operating Procedures (SOPs). This role requires advanced leadership skills, strong technical expertise, and the ability to manage cross-functional teams to ensure high-quality data is collected, cleaned, and reported in a timely manner. The CDM will work closely with biostatisticians, clinical teams, and regulatory affairs to support the success of clinical trials.
MAJOR DUTIES AND RESPONSIBILITIES:

• Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting.
• Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans.
• Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar).
• Develop and oversee maintenance all data management documentation for all clinical studies.
• Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks.
• Oversee data validation processes, including data cleaning, discrepancy management, and query resolution.
• Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA).
• Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process.
• Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations.
• Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes.
• Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution.
• Serve as the primary point of contact for data management vendors and external partners, ensuring effective communication and timely issue resolution.
• Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency
• Develop, implement, and continuously improve clinical data management processes and systems.
• Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies.

EXPERIENCE REQUIREMENTS:

• Bachelor’s or Master’s degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred.
• Strong understanding of data structure and data systems.
• Minimum of 5+ years of experience in clinical data management
• Proven experience managing data across multiple phases of clinical trials
• Proficiency with EDC systems (e.g., Medidata Rave, Medrio).
• Strong understanding of CDISC standards (CDASH, SDTM, ADaM) as well as WHO Drug and MedDRA coding.
• Familiarity with data reporting tools is a plus.

OTHER QUALIFICATIONS

• Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA,EMA), and GCP standards.
• Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication, problem-solving, and decision-making skills.
• Ability to work collaboratively with cross-functional teams and manage
• relationships with external vendors.
• Preferred Certifications: Certified Clinical Data Manager (CCDM) or similar certification is preferred.

BENEFITS AND PERKS:

Our culture is rooted in our core values every day, in everything we do. 

Our benefits focus on the 5 dimensions of wellbeing: physical, financial, emotional, career and community.  Physical benefits include Medical – PPO & HSA with co-contribution, Dental, Vision, Accident Insurance, Critical Illness, Hospital Indemnity, and onsite Tonal & Peloton. Financial benefits include HSA/FSA, 401k with company match, Lifestyle Spending Account, Long Term Disability, Life Insurance, a monthly stipend to cover phone and tech costs, employee discounts, and weekly office lunches. Emotional benefits include Employee Assistance Program, 5 free counseling sessions per issue per year, 80 hours sick leave, 13 holidays, and flexible vacation (exempt employees). Career and Learning & Development opportunities with Aerin led leadership trainings. Community initiatives which include Aerin “give back” week, family days as well as Aerin holiday giving.