Merck KGaA Darmstadt Germany - West Point, PA

posted 3 months ago

Full-time - Mid Level
Onsite - West Point, PA
Chemical Manufacturing

About the position

As a Clinical 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. Your primary responsibility will be to ensure that clinical databases and data transfer files align with established specifications, maintaining high standards in accordance with our clinical database 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, including external CROs and vendors, to incorporate their requirements into all deliverables. Additionally, you will develop transformation logic and scripts to streamline data for analysis and reporting. A rewarding aspect of this position is the opportunity to provide ongoing training and development to other Clinical Database Developers on existing standards. You will also engage in various activities such as task forces, testing new systems, and coordinating CDS technical initiatives. Supporting the clinical database manager or supervisor in project planning, manpower projections, and resource allocation across therapy areas will be another significant responsibility of yours.

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, Inform Architect, Central Designer, 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 across functional areas.
  • 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, clinical database cleaning process, and 21 CFR Part 11.

Nice-to-haves

  • Experience with additional Clinical Data Management Systems.
  • Familiarity with data visualization tools.
  • Knowledge of statistical analysis software.

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
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