Principal Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage comprehensive clinical data management activities for various intricate global projects and programs.

• Ensure effective planning and management of data management deliverables, timelines, budgets, and resources.

• Supervise the creation and assessment of Data Management Plans, database specifications, edit checks, and data transfer agreements.

• Oversee user acceptance testing, data cleaning strategies, reconciliation activities, and readiness for database lock.

• Track study progress using metrics and identify, communicate, and mitigate project risks and changes in scope.

• Act as the primary representative for data management in both internal and sponsor-facing meetings.

• Serve as a subject matter expert on data management processes, promoting process optimization, training, quality enhancement, and CAPA activities.

• Mentor and assist data management colleagues while contributing to departmental initiatives and operational excellence programs.

• Aid in business development activities, sponsor audits, inspections, and engagements with stakeholders.

⛳️ Requirements

• A Bachelor's degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience.

• At least 7 years of clinical data management experience or related experience in the pharmaceutical, biotechnology, or medical device sectors.

• In-depth knowledge of clinical data management best practices, technologies, and processes that support clinical trials.

• Advanced familiarity with clinical trial documentation and processes, including protocols, CRFs, statistical analysis plans, and study reports.

• Demonstrated ability to independently lead and manage complex global clinical data management projects.

• Strong analytical, problem-solving, and decision-making abilities with exceptional attention to detail.

• Excellent communication and interpersonal skills, capable of effective collaboration with both internal and external stakeholder groups.

• Proficient in English.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable workplace.

• Equal employment opportunities.

• Transparent compensation and pay equity.