Senior Specialist, Lead Database Developer

$111,400 - $175,300/Yr

Merck & Co. - West Point, PA

Full-time - Mid Level

Onsite - West Point, PA

Chemical Manufacturing

About the position

As a Senior Specialist, Lead Database Developer, you will play a crucial role in advancing healthcare by creating and developing clinical databases and data transfer files. This position offers a unique opportunity to contribute to a team dedicated to delivering innovative solutions for the prevention and treatment of diseases affecting both humans and animals. You will be responsible for ensuring that all clinical databases align with written specifications and adhere to established standards, SOPs, and Process Guidelines. In this role, you will lead and participate in the review of electronic case report forms (eCRF) and edit checks, as well as the programming of edit checks and scripts that facilitate the transfer of electronic data files into the Clinical Data Management System (CDMS). Collaboration is key, as you will work closely with study teams and external CROs/Vendors to incorporate their requirements into all deliverables. Additionally, you will develop transformation logic and scripts to streamline data for analysis and reporting, enhancing the efficiency of the clinical data management process. A rewarding aspect of this position is the opportunity to provide ongoing training and development to other Clinical Database Developers, ensuring that the team maintains high standards of quality and compliance. You will also engage in various activities, including task forces, testing new systems, and coordinating technical initiatives within the Clinical Data Services (CDS) team. Supporting the clinical database manager/supervisor in project planning, manpower projections, and resource allocation across therapy areas will be another key responsibility, allowing you to contribute to the overall success of the projects you are involved in.

Responsibilities

• Create and develop clinical databases and data transfer files according to specifications.
• Uphold clinical database standards, SOPs, and Process Guidelines.
• Lead and participate in the review of electronic case report forms (eCRF) and edit checks.
• Program edit checks and scripts for data transfer into the Clinical Data Management System (CDMS).
• Collaborate with study teams and external CROs/Vendors to incorporate requirements into deliverables.
• Develop transformation logic and scripts for data analysis and reporting.
• Provide ongoing training and development to other Clinical Database Developers.
• Engage in task forces and testing of new systems.
• Coordinate CDS technical initiatives and support project planning.

Requirements

• Bachelor's degree in computer science or equivalent professional experience in software design and development.
• Minimum of 4 years of database development or data programming experience (Oracle PL/SQL and Object-Oriented Programming).
• At least 2 years of experience in clinical databases development or programming.
• Demonstrated technical proficiency in Clinical Data Management Systems (e.g., Inform, Medidata Rave).
• Working knowledge of MS Windows/Office software and exposure to web-based applications.
• Strong sense of urgency and customer focus with the ability to maintain good working relationships.
• Solid project management skills.
• Excellent leadership, verbal and written communication, interpersonal, and organizational skills.
• Desire and ability to learn new processes and technologies.
• Broad knowledge of Clinical Development and Regulatory Affairs requirements.
• Ability to multi-task, work independently, and communicate effectively.
• Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, and clinical database cleaning process.

Benefits

• Bonus eligibility
• Long-term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days