Clinical Data Manager - Python Scripting

We are seeking an experienced Clinical Data Manager II with strong technical skills to support clinical trial data management, database development, and workflow automation. We are looking for someone who takes initiative, works independently, and can identify opportunities to improve data management processes while collaborating with clinical operations, biostatistics, and other cross-functional teams.

Clinical Data Manager II - Python Scripting
Work Arrangement: Hybrid – Minimum 3 Days Onsite Per Week
 
Position Overview
We are seeking an experienced Clinical Data Manager II with strong technical skills to support clinical trial data management, database development, and workflow automation.
This position is responsible for ensuring clinical trial data is accurate, complete, and compliant with regulatory requirements. The ideal candidate will have hands-on experience with clinical data management, Electronic Data Capture (EDC) systems, and advanced Python scripting to automate data cleaning, validation, and reporting processes.
We are looking for someone who takes initiative, works independently, and can identify opportunities to improve data management processes while collaborating with clinical operations, biostatistics, and other cross-functional teams.
 
Key Responsibilities
Clinical Data Management & Database Development

• Manage clinical trial data collection, cleaning, validation, and quality control activities.
• Support the design, development, testing, and maintenance of clinical databases and EDC systems.
• Participate in User Acceptance Testing (UAT), develop data validation specifications, and review edit checks.
• Oversee data query generation, reconciliation, and resolution to maintain data accuracy and completeness.
• Work with clinical trial sites and Contract Research Organizations (CROs) to resolve data discrepancies.

 Python Scripting & Process Automation

• Develop and maintain Python scripts to automate data extraction, cleaning, validation, and reporting.
• Identify inefficiencies in clinical data workflows and implement technical solutions to improve accuracy and processing time.
• Create automated data quality checks and reporting tools to reduce manual processes.
• Collaborate with technical and biostatistics teams to support data transformations and standardization, including CDISC SDTM and CDASH.

 Regulatory Compliance & Documentation

• Ensure clinical data management activities comply with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and internal Standard Operating Procedures (SOPs).
• Maintain accurate documentation to support regulatory inspections, audits, and clinical trial milestones.
• Follow 21 CFR Part 11 requirements related to electronic records and data integrity.
• Partner with Clinical Operations, Biostatistics, Quality Assurance, and Site Management teams to meet study objectives and timelines.

 Required Qualifications
Education & Experience

• Bachelor's degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field.
• Minimum of 2 years of hands-on clinical data management experience within clinical trials.
• Experience managing clinical trial data, including data cleaning, validation, reconciliation, and query resolution.

 Technical Skills

• Advanced hands-on Python programming experience, including scripting, data manipulation, and workflow automation.
• Experience developing Python scripts to automate clinical data validation, cleaning, extraction, or reporting.
• Hands-on experience with at least one EDC platform, such as Medidata Rave, Veeva Vault CDMS, REDCap, or Oracle InForm.
• Experience supporting EDC database development, testing, data validation, or UAT.
• Strong understanding of GCP, 21 CFR Part 11, and clinical trial regulatory requirements.

 Professional Skills

• Strong analytical and problem-solving abilities with excellent attention to detail.
• Ability to manage multiple responsibilities and work independently.
• Strong communication skills and the ability to explain technical information to non-technical stakeholders.
• Experience collaborating with cross-functional clinical trial teams.
• Proactive approach to identifying and resolving data management challenges.

 Preferred Qualifications

• Master's degree in a related field.
• Experience with SQL, R, or SAS.
• Familiarity with CDISC standards, including SDTM and CDASH.
• Experience developing automated reporting tools or improving clinical data management workflows.

 Work Arrangement
This is a hybrid position requiring a minimum of three days onsite each week.
 


Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.