Program Manager, Clinical Database Services

$130,960 - $206,200/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Mid Level

Remote - Rahway, NJ

Chemical Manufacturing

About the position

The Clinical Database Manager oversees and coordinates clinical database activities for clinical programs, ensuring adherence to standards and timelines. This role involves interfacing with study teams, managing database development, and providing ongoing support to various departments. The manager also leads initiatives for process improvement and contributes to the recruitment and training of Clinical Database Developers.

Responsibilities

• Oversees and coordinates clinical database activities for clinical programs including the review of eCRFs, edit check specifications, and database development.
• Ensures adherence to clinical database standards, SOPs, and Process Guidelines.
• Plans appropriately to ensure adherence to timelines for all clinical database services deliverables and escalates risks to management.
• Interfaces with members of study teams to integrate study team requirements into all deliverables.
• Interfaces with CDS manager/supervisor to assure consistency of technical and process strategies.
• Aligns others around a positive direction and develops challenging but achievable objectives that support organizational goals.
• Interacts and communicates clinical database processes and requirements to external vendors.
• Leads and participates in extra activities including improvement task forces, automations, and testing of new systems.
• Contributes strategies and innovative solutions to enhance processes and increase productivity.
• Provides ongoing clinical database support to other departments.
• May perform development activities such as database development or Peer Review when necessary.
• Provides oversight to Clinical Database Developers and participates in their recruitment, mentoring, and training.
• Provides input into the performance appraisals of Clinical Database Developers to management.
• Ensures adherence to standards in the development, documentation, and maintenance of data dictionaries.
• Acts as a Subject Matter Expert (SME) of clinical database and Electronic Data Capture activities if technically trained.
• Supports departmental efforts to simplify and standardize procedures, sharing best practices and leading continuous improvement efforts.
• Conducts management and functional area meetings, contributing expertise through presentations.

Requirements

• Bachelor's degree in computer science or related disciplines.
• Minimum of 5 years pharmaceutical experience within clinical research.
• Experience in technology acquisition and implementation.
• 2 years project management experience (either one project for a year or multiple projects totaling one year).
• High level of understanding with the design and development of electronic Case Report Forms (eCRFs), clinical databases, and data capture methods.
• Knowledge of Electronic Data Capture Systems or Data Management Systems.
• Solid knowledge of MS Windows/Office software and exposure to web-based applications.
• 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 Team.
• Strong organizational, time management, and multi-project coordination skills.
• Broad knowledge of Clinical Development and Regulatory Affairs requirements.
• Ability to multi-task and work independently.

Nice-to-haves

• Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.

Benefits

• Bonus eligibility
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days