Job Description

Job Description

Job Description

Summary

The Clinical Data Manager will be responsible for the oversight and management of clinical trial data specifically related to In Vitro Diagnostics (IVD) studies. This role involves working closely with cross-functional teams to ensure data accuracy and compliance, managing databases, and supporting the clinical development of diagnostic devices. The Clinical Data Manager will ensure that all data collected during IVD trials is robust, reliable, and compliant with regulatory standards, with a specific focus on leveraging Veeva systems for data management. This position will be remote, full-time reporting to the Associate Director of Data Management.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Data Management Planning:
   1. Develop and implement comprehensive Data Management Plans (DMPs) tailored to the unique needs of IVD studies, including diagnostic assay performance and clinical utility.
   2. Collaborate with the project team to define database specifications, including eCRF design and database setup in the context of IVD trials, using Veeva Vault CDMS.
   3. Ensure that data collection methods are optimized for the specific requirements of IVD clinical trials, such as handling large volumes of assay data and ensuring traceability of diagnostic results.
2. Database Management:
   1. Oversee the setup, testing, and maintenance of clinical trial databases, ensuring they are configured to handle complex IVD data structures.
   2. Ensure databases are compliant with IVD-specific regulatory requirements (e.g., IVDR in Europe, FDA 21 CFR Part 820), with a focus on the integrity and traceability of diagnostic data.
3. Data Collection and Validation:
   1. Coordinate data entry, data cleaning, and validation processes for IVD trials, ensuring that diagnostic data, including test results, sample data, and calibration details, are accurately captured and verified.
   2. Perform quality checks and resolve data discrepancies, with particular attention to the technical validity of diagnostic data and its correlation with clinical outcomes.
   3. Monitor data entry progress and ensure timely completion, leveraging the EDC reporting tools.
4. Data Analysis and Reporting:
   1. Generate and review data listings, summaries, and reports.
   2. Assist in the preparation of data for statistical analysis, ensuring that all diagnostic data is appropriately formatted for regulatory submissions.
   3. Provide support for interim and final database locks, ensuring that diagnostic data is fully validated and ready for analysis.
5. Documentation and Compliance:
   1. Ensure all data management documentation is accurate, complete, and compliant with SOPs, clients and regulatory requirements.
6. Cross-Functional Collaboration:
   1. Work closely with biostatistics, clinical operations, regulatory, and IT teams to ensure seamless data management processes tailored to IVD trials.
   2. Act as the primary point of contact for data management activities with external vendors and stakeholders.
7. Training and Support:
   1. Train clinical site staff on data management procedures, software, and specifically on Veeva Vault CDMS, with a focus on the nuances of IVD data.
   2. Provide ongoing support and troubleshooting for data-related issues, particularly those related to the management of diagnostic data.

Required Education and Experience

1. Bachelor’s degree in life sciences, medical technology, bioinformatics, computer science, or a related field. Advanced degree preferred.
2. Minimum of 3-5 years of experience in clinical data management, with a strong preference for experience in the IVD or medical device industry.
3. Experience working in a CRO environment with a focus on IVD studies is highly desirable.

Knowledge and Skills

1. Technical Skills:
   1. Proficiency in clinical data management systems (e.g., Medidata, Oracle Clinical, REDCap) with specific experience in Veeva Vault CDMS is preferred
   2. Strong understanding of regulatory requirements specific to IVD products (e.g., FDA 21 CFR Part 820, IVDR, CLIA).
   3. Familiarity with programming languages (e.g., SAS, SQL) is a plus.
2. Soft Skills:
   1. Excellent organizational and time management skills.
   2. Strong attention to detail and problem-solving abilities.
   3. Effective communication and interpersonal skills.

Supervisory Responsibility

This position may have supervisory responsibilities in future.

Why Join Us:

• Be part of a cutting-edge biotech company that is making a real impact in life sciences.
• Collaborate with leading scientists and professionals in the field.
• Competitive salary, benefits, and career advancement opportunities.
• A fast-paced and innovative environment with a focus on growth and development.

This role is a fantastic opportunity for an experienced CDM professional to contribute to an industry that is improving health outcomes worldwide.

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