Specialists, Clinical Data Management

About the role

Join our team as a Specialist in Clinical Data Management to support our clinical studies. In this role, you'll be responsible for all clinical programming (including reporting and analytics) deliverables, including Oracle, Veeva platforms, and external data captured in support of clinical studies.

Responsibilities

• Design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research, and Global Safety.
• Review the technical feasibility of study team proposed programming/reporting and technically implement them.
• Work effectively among teams to communicate issues and ideas to improve business along with understanding of Protocol.
• Support the development and reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of customer needs.
• Perform ongoing support for In-Life Reports.
• Ensure Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
• Participate in extra activities including 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 like Databricks, Python, SAS, SQL/PL SQL, Power BI, and AI-related tools.
• Solid knowledge of MS Windows/Office software and exposure to web-based applications.
• Solid knowledge of System Development Lifecycle Management and system validation.
• Ability to establish and maintain good working relationships with different functional areas.
• Strong sense of urgency and customer focus.
• Excellent communication skills and ability to interact effectively with Study Teams.
• Strong organizational and problem-solving skills.
• Desire and ability to learn new processes and technologies.
• Ability to multi-task and work independently.
• 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, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

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

Schedule

• 10% travel requirements.
• Flexible work arrangements: Hybrid.