Remote Clinical Data Manager

Summary

The job is for a Clinical Data Manager at Foresight Diagnostics, a molecular diagnostics company specializing in non-invasive cancer detection technologies. The role involves supporting clinical trials and collaborating with various departments. The position is hybrid or fully remote, with periodic travel. The salary range is between $90,000-105,000, and the application deadline is August 15, 2024.

Requirements

• 3-5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry
• Strong understanding of clinical trial processes, data management principles and regulatory guidelines
• Proficiency in electronic data capture (EDC) systems and clinical data management software
• Familiarity with relevant regulations and guidelines, like GCP and CDISC standards
• Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical
• Excellent attention to detail with problem-solving and analytical skills
• Strong organizational and time management abilities

Responsibilities

• Support clinical data management activities for biopharma partnerships, Foresight-sponsored studies (prospective and retrospective), investigator-initiated trials, and other analytical needs as required
• Develop and maintain data management documentation, including data management plans, relevant portions of study protocols, case report forms (CRF), and CRF completion guidelines
• Develop data transfer file requirements and templates for exchange of clinical data, MRD testing data, and biospecimen manifests
• Perform data cleaning activities, including discrepancy management and query resolution for prospective data collection and dataset for retrospective studies
• Data aggregation and internal database development for storage of laboratory and testing data related to clinical trial conduct and evaluation of MRD test performance
• Generate and review clinical study dashboards and data summaries for use in tracking study progress, centralized data monitoring, and study reports
• Design case report forms (CRFs), electronic data capture (EDC), and electronic patient-reported outcomes (ePRO) systems for data collection
• Conduct data validation checks and implement quality control measures to ensure accuracy and completeness
• Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval
• Collaborate with study team members to resolve data-related issues and discrepancies
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations
• Contribute to the development and validation of data management software tools

Preferred Qualifications

• Experience in molecular diagnostics and oncology
• Certification in clinical data management (like CCDM)
• Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM)
• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Benefits

• Offering a salary between $90,000-105,000
• Eligible for equity offerings
• Paid vacation, sick time, and parental leave (if applicable)
• Medical, dental, vision, life, disability coverage
• Flexible spending accounts
• 401k with company match