Clinical Data Specialist

Summary

Join Foresight Diagnostics, a venture-backed molecular diagnostics company, as a Clinical Data Manager to support the planning and execution of clinical trials. Collaborate with internal teams (Medical Affairs, Quality Assurance, Regulatory Affairs, Production) and external stakeholders (biopharma partners and CROs). Focus on programmatic aggregation of laboratory and clinical data, data visualization, data cleaning, query reconciliation, and clinical data infrastructure. The role involves managing clinical data for various studies, developing data management documentation, performing data cleaning, generating reports, and ensuring compliance with regulations. This position offers a competitive salary ($105,000-$130,000) and equity offerings. The deadline to apply is June 30, 2025.

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 and SQL
• 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 projects requiring data support
• Develop and maintain data management documentation, including data management plans and relevant portions of study protocols
• 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 IDE/IVD trial conduct
• Generate and review clinical study dashboards and data summaries for use in tracking study progress, centralized data monitoring, and study reports
• 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)
• Understanding of data privacy and protection regulations (e.g., GDPR)
• Effective communication and interpersonal skills to collaborate with other teams
• Proficiency in programming tools such as R (and ecosystem tools like R markdowns and notebooks), or Python (jupyter notebooks)
• Proficiency in business intelligence tools, data visualization, and other tools used for data driven decision making

Benefits

• Paid vacation
• Sick time
• Parental leave (if applicable)
• Medical, dental, vision, life, disability coverage
• Flexible spending accounts
• A 401k with company match