Lead Data Engineer

• Develop Power BI dashboards, reporting tools, and user-friendly data products that enable stakeholders to access insights independently and reduce reliance on manual reporting processes. 

• Design, develop, and maintain automation solutions using Power Automate, APIs, and other technologies to streamline evidence management, reporting, data updates, and operational workflows. 

• Develop integrations between platforms, applications, and data sources to enable efficient information flow, reduce duplicate effort, and improve the overall user experience. 

• Develop validation processes, quality checks, and monitoring approaches that improve confidence in data used across the organization. 

• Create reusable tools, workflows, and technical solutions that can be leveraged across multiple projects and business needs. 

• Serve as the technical lead for Clinical Data Sciences automation, BI, and technology initiatives.

• Collaborate with stakeholders across Clinical Research, Medical Affairs, Regulatory Affairs, Market Access, and other functions as needed to support CDS-led initiatives and ensure solutions align with business objectives. 

• Partner closely with the Clinical Data Sciences Manager and growing CDS team to translate strategic priorities, business needs, and evidence management challenges into scalable technical solutions 

What will you need: 

Basic qualifications: 

• Master’s degree in a scientific or healthcare-related field. 

• Minimum 8-10 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry. Experience in medical devices company is preferred. 

• Strong understanding of clinical trial processes, data management principles and regulatory guidelines. 

• Proficiency in automation, Microsoft Power Suite 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. 

Preferred qualifications: 

• Certification in clinical data management (like CCDM). 

• Knowledge of MS Project and analytical capabilities. 

• 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.