Clinical Data Manager (East Coast Remote)

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

Remotely based on the U.S. East Coast or in the EU, the Clinical Data Manager is responsible for the management of clinical trial data collection and data processing across SELUTION DEB trials. The Clinical Data Manager designs programs and validates databases, creates data management plans, develops case report forms, oversees data processing, generates queries, and conducts data cleaning activities throughout the lifecycle of a trial. The Clinical Data Manager leads end-to-end clinical data management across SELUTION clinical trials and oversees any CRO/vendor execution of data management activities. This role is directly involved in the success of the organization in improving patient care and coordinating with clinical sites.

Key Responsibilities

• Provide clinical data management support across SELUTION DEB clinical studies.
• Partner with key stakeholders across Clinical Operations, Biostatistics, Safety, and Regulatory to deliver timely, compliant, inspection-ready, and high-quality data to support analyses, submissions, and data-driven decisions
• Develop the Data Management Plan (DMP) and maintain DMP throughout lifecycle of study project while ensuring DMP is followed according to study design and requirements.
• Develop Case Report Form (CRF) creation, including CRF specifications and CRF completion guidelines
• Database programming - Develop and lead the design, creation, testing, and implementation of electronic data capture ( EDC) database build. Ensuring user requirements, edit rules/checks, query logic, data validations, and data transfer specifications throughout.
• Generate the user acceptance testing (UAT) of eCRF build and validation documents, included but not limited to, edit check documents, issue logs, and UAT summary reports.
• Maintain databases throughout lifecycle of study, ensure users access, perform updates
• Develop reports/trackers within the database
• Validate clinical trial data by regular data cleaning to ensure consistency, integrity and accuracy based on project specific guidelines and protocol requirements.
• Define and create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management
• Provide input into clinical research documents (e.g. Protocols and Statistical analysis plans)
• Oversee CRO and provide feedback related to data management operations, issues and trends in performance
• Provide database exports as applicable
• Responsible for archival of study databases and related
• Coordinate and communicate with database vendors

**Strategic Impact**

• Data integrity is the utmost goal for the Clinical Data Manager. This role helps to deliver high-quality data to support clinical study analyses and regulatory submissions.

**Key Interactions**

• Supervisor : Sr Dir Clinical Operations
• Internal Interactions : This role will interact heavily with Clinical Study Management teams across all projects, Biostatistics, Safety, Regulatory, and cross-functionally as needed
• External Customer Interactions : This role will work CROs, EDC vendors, physicians and clinical research teams

Qualifications

**Required Experience**

• Bachelor’s degree or equivalent
• Minimum of 8 years’ clinical experience in Medical Device studies
• Minimum of 5 years’ clinical data management experience, with experience using and developing multiple clinical data management systems
• Data management experience on US IDE trials
• Certified database programmer

**Competencies \& Skills**

• Precise, Rigorous, Detail-Oriented
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Strong interpersonal and conflict management skills
• Ability to take independent decisions and analyze complex issues, capable problem-solver
• Supportive, keen to promote quality through example and continuous support
• Team Leader, ability to inspire and support a team
• Ability to thrive in a fast-paced environment while remaining flexible, proactive, resourceful and efficient
• Knowledgeable in ICH GCP guidelines and industry standards applicable to data capture and data management process to ensure the appropriate conduct of clinical studies
• Knowledgeable in Power BI, Smartsheet, or other data/dashboard tools
• Global, International Orientation
• Fluent in English

Pay / Compensation

The expected pre-tax pay rate for this position is $114,950 – 165,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Preferred Qualifications

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.