Specialists, Clinical Data Management

Join our team to support clinical studies through clinical data management, programming, and analytics. This role involves working with Oracle, Veeva platforms, and external data to ensure quality and timely availability of clinical data.

Responsibilities

• Design, build, maintain, test, and document data review processes based on written specifications from Global Clinical Data Management, Clinical Research, and Global Safety.
• Review the technical feasibility of study team-proposed programming/reporting and implement them.
• Collaborate with teams to communicate issues and ideas, improving business processes and protocol understanding.
• Support the development and reporting for data cleaning, medical review, clinical monitoring, and safety reports.
• Provide ongoing support for In-Life Reports, ensuring Change Requests and Incident Reports are documented, signed off, tracked, and reported to management.
• Participate in study improvement task forces, automation initiatives, testing of new systems, and ongoing training and mentoring.

Requirements

• Associate degree with a minimum of 3 years’ experience in clinical data programming, data engineering, or related data-management/clinical operations functions, OR
• Bachelor’s Degree with a minimum of 2 years’ experience in clinical data programming, data engineering, or related data-management/clinical operations functions, OR
• Advanced Degree (master’s or doctorate) with prior experience in clinical development and/or clinical data programming, data engineering, or related data-management/clinical operations activities (preferred).

Skills

• Strong technical proficiency in Clinical Data Management/Reporting Systems (e.g., Databricks, Python, SAS, SQL/PL SQL, Power BI) and AI-related tools.
• Solid knowledge of MS Windows/Office software and web-based applications.
• Understanding of System Development Lifecycle Management and system validation.
• Ability to establish and maintain effective working relationships across functional areas.
• Strong sense of urgency, customer focus, and organizational skills.
• Excellent communication and problem-solving skills.
• Ability to multi-task, work independently, and adapt to new processes and technologies.
• Understanding of the drug discovery process, FDA regulations, GxP guidelines, and ICH.

Pay

The salary range for this role is $87,300.00 - $137,400.00. An employee’s position within the salary range will be based on factors including education, qualifications, certifications, experience, skills, geographic location, and business needs. The successful candidate will also be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Comprehensive medical, dental, vision, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

Schedule

• Hybrid work arrangement.
• 10% travel requirements.