Specialist, Clinical Data Management – Hybrid

Responsibilities

Assumes responsibilities for all clinical programming (including reporting and analytics) deliverables, including Oracle and Veeva platforms, as well as external data captured in support of the clinical studies. Coordinates and participates in the design, build, maintenance, testing, and documentation of data review based on written specifications established by Global Clinical Data Management, Clinical Research, and Global Safety. Reviews the technical feasibility of study team proposed programming/reporting and implements them technically.

Works effectively with the team to communicate issues and ideas to improve the business, along with a strong understanding of the protocol. Supports the development and reporting for data cleaning, medical review, clinical monitoring, and safety reports to ensure quality and timely availability in support of our customer needs. Performs ongoing support for In‑Life Reports. Change requests and incident reports are fully documented, signed off, tracked, and reported to upper management.

Participates in extra activities, including but not limited to study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.

B.A. or B.S. degree, preferably in mathematics, science, a healthcare‑related discipline, or computer science; or relevant Pharma skills and experience.

• 4+ years’ experience in SQL, PL‑SQL, and PowerBI.
• Strong technical proficiency in Clinical Data Management/Reporting Systems such as Databricks, Python, SAS, etc., along with AI‑related tools.
• Solid knowledge of MS Windows/Office 365 and exposure to web‑based applications.
• Understanding 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 effective interaction with the study team.
• Strong organizational and problem‑solving skills.
• Desire and ability to learn new processes and technologies.
• Ability to multi‑task, work independently, and communicate effectively.
• Understanding of drug discovery process, FDA regulations, GxP guidelines, and ICH clinical trial guidelines.

Range: $87,300.00 – $. Eligible for annual bonus and long‑term incentive, if applicable.

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

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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