Job Overview
We are seeking an experienced Clinical Data Manager / Study Database Manager to support clinical study database development, maintenance, and validation. The ideal candidate will have strong analytical and critical-thinking skills, experience with clinical data management systems, and a solid understanding of regulatory compliance and data quality standards.
This role involves cross-functional collaboration to ensure clinical databases meet study requirements, industry standards, and regulatory guidelines.

Key Responsibilities
Design, configure, test, debug, and document clinical study databases in accordance with the software development lifecycle.
Lead and support clinical database setup, including edit check programming.
Review Case Report Form (CRF) designs, study protocols, database specifications, functional requirements, and edit check specifications.
Ensure database standards, conventions, data quality, and regulatory compliance are maintained.
Collaborate with cross-functional teams to deliver high-quality and consistent database solutions.
Troubleshoot clinical data management system issues and recommend effective solutions.
Identify, escalate, and resolve system errors and service issues to minimize downtime.
Contribute to the review of clinical research protocols, study reports, and statistical analysis plans.
Manage multiple priorities while working independently and collaboratively.

Required Qualifications
Minimum 5 years of experience working with a medical device, pharmaceutical, or biopharmaceutical company.
Minimum 2 years of hands-on experience with clinical data management systems, including clinical study database setup and edit check programming.
Strong analytical, problem-solving, and critical-thinking skills.
Excellent communication and collaboration skills.
Ability to lead discussions, influence team decisions, and manage complex regulated studies.

Preferred Qualifications
Experience with Oracle Clinical, Oracle Clinical Inform, Oracle Life Sciences Cloud, or other clinical data management systems.
Knowledge of FDA 21 CFR Part 11 requirements and Good Clinical Practice (GCP) guidelines for clinical data handling.
Experience supporting clinical database development, validation, and regulatory compliance.

Interested or know someone who would be a great fit? Please reach out via direct message or share your updated resume.
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Clinical Data Manager

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