Job Description
What will you do:
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.