Clinical Data Manager

Why CorMedix?

If you are interested in joining an entrepreneurial team, focused on bringing life-saving therapies to market for critical unmet medical needs, consider applying for a role at CorMedix. The culture at CorMedix is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare.

CorMedix’s greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high-precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose. We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs.

Company Description:

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com.

Position:

The Clinical Data Manager (CDM) is responsible for overseeing the collection, management, and analysis of clinical trial data to ensure its integrity, accuracy, and regulatory compliance. Working closely with cross-functional teams, the CDM plays a pivotal role in ensuring that clinical data supports the successful development and approval of biopharmaceutical products.

Primary Responsibilities:

Data Management and Oversight

• Design, implement, and maintain data management plans (DMPs) and processes for clinical trials.
• Ensure high-quality data collection, entry, and validation in alignment with regulatory standards (e.g., FDA, EMA, ICH-GCP).
• Develop and oversee database structures, edit checks, and data validation procedures to ensure data integrity.

Collaboration and Communication

• Collaborate with clinical trial teams, statisticians, and external vendors to coordinate data management activities.
• Communicate data-related milestones, risks, and solutions to internal and external stakeholders.
• Act as the primary point of contact for external data vendors, ensuring compliance with service level agreements.

Regulatory Compliance and Documentation

• Ensure adherence to regulatory requirements and guidelines, including Good Clinical Data Management Practices (GCDMP).
• Prepare, maintain, and archive essential data management documentation, including case report forms (CRFs) and annotated CRFs.
• Support data audits and inspections by regulatory authorities.

Data Analysis and Reporting

• Perform quality control checks and generate data summaries, listings, and tables for interim and final analyses.
• Collaborate with biostatistics to ensure readiness for database lock and analysis.

Skills and Requirements:

• Strong knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
• Excellent attention to detail, problem-solving skills, and ability to manage multiple projects simultaneously.
• Proficient in programming languages such as SAS, R, or SQL (preferred).
• Strong communication and interpersonal skills to effectively work in cross-functional teams.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Health Informatics, Biostatistics, or related field.
• Minimum of 3–5 years of experience in clinical data management, preferably in a biopharmaceutical or CRO environment.
• Proficiency with clinical data management systems (e.g., Medidata RAVE, RedCap, Castor, Oracle Clinical) and electronic data capture (EDC) platforms.

EEO Statement:

CorMedix is an equal opportunity employer. The Company is committed to providing a safe, respectful, and professional work environment that is free from all forms of unlawful discrimination, harassment (including sexual harassment), and retaliation, and complies with all applicable laws prohibiting such conduct. CorMedix does not discriminate against any individual on the basis of race, religion, color, national origin, ancestry, sex, marital/civil union/domestic partner status, family or parental status, sexual orientation, age, disability, or any other status protected under applicable federal, state, or local law.