Clinical Data Analyst II

Specific Duties and Responsibilities

Collaborate with clinical project team to clarify and finalize user requirement specifications for clinical data analysis tools and reports. Communicate with selected vendors and/or build reports and / or tools to meet clinical user requirements. *

Lead technical projects like the specification, programming and testing of risk-based monitoring reports, complex cross-form data cleaning reports, and integrations between systems. *

Contribute to the development and maintenance of the data warehouse used to manage libraries of clinical study data including image, source document, and data files.

Develop dashboards and reports to support the clinical study team by choosing the right programming technique and software tool for each problem. *

Independently program reports to execute trial-specific data review/cleaning plans

Design, write, and maintain code to perform complex data transformations, including data import/export, transposition, and ETL processes; ensure accuracy, efficiency, and reproducibility. *

Integrate data from multiple systems to create reports and dashboards that meet the clinical study needs.

Automate routine data processing and reporting tasks to improve efficiency and reduce manual effort

Write, validate, and optimize analytical programming scripts and report specifications

Assist in the setup of programming timelines and deliverables for projects as required.

Assist in addressing external application vendor issues, integrations, and implementations.

Provide support for implementation of upgrades and new modules of remotely hosted vendors, acquiring all necessary documentation.

Apply programming techniques to improve efficiency, scalability, and quality of data processes, including evaluating alternative coding approaches and tools

Partner with organizational stakeholders to create and implement data analytics best practices

Contribute to the build and testing of clinical study databases, by defining study requirements specifications for data validations with minimal supervision and accurately conducting testing of the data validations. *

Participate in and contribute to project discussions. Communicate with team members on a regular basis.

Utilize reports and data collection technology to identify possible data errors and questionable data trends

Participate in audits as required.

Provide support to senior and manager-level clinical data analysts as needed.

Mentor and support less experienced clinical data analyst staff, peers, and other department staff. *

Proactively provide process improvement feedback to management and provide input in SOP and standards updates/development.

Maintain and continue to gain a broad overall knowledge in the field of clinical data analysis and clinical data management.

Responsible for attending training classes and professional meetings as required.

Create training materials for clinical users and developers

Document data processes and workflows to support reproducibility

Create analytical data models and tools to help empower clinical teams

Follow data standards policies, procedures, practices, and regulations for clinical data analysis reports and tools throughout the process of collection and submission of clinical data.

Further programming and reporting skills independently

Provide technical support and training on reports and tools for clinical staff.

Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *

Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *

Ensure other members of the department follow the QMS, regulations, standards, and procedures.

Perform other work-related duties as assigned

*Indicates an essential function of the role

Required Qualifications

Minimum education and experience

Bachelor's degree in mathematics, computer science, economics, life science, or related field with 2+ years of experience, or equivalent combination of education and experience

Solid hands-on knowledge of at least one programming language (e.g., Python, SAS, R, MATLAB, C Sharp, Visual Basic, SQL) required

Preferred Qualifications

Master’s degree preferred

Experience in the analysis of medical or scientific data is strongly preferred

Relational database experience preferred

An understanding of the software development lifecycle process is preferred

Experience with clinical database (e.g., Medrio, InForm, RedCap, OpenClinica, Medidata RAVE) a plus.

Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite) a plus.

Able to take initiative on own project responsibilities

Excellent attention to detail and ability to multi-task considering established project priorities are essential

Demonstrated expertise in use of required technology

Medical device, pharmaceutical, biotech, or other regulated industry experience desired

Strong oral, written, and interpersonal communication skills

Proficiency with MS Word, Excel, and PowerPoint

Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Working Conditions

General office environment.

Potential exposure to blood-borne pathogens.

Requires some lifting and moving of up to 15 pounds.

Must be able to move between buildings and floors.

Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

Must be able to read, prepare emails, and produce documents and spreadsheets.

Must be able to move within the office and access file cabinets or supplies, as needed.

Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.