Program Clinical Data Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Independently lead data management efforts across various intricate global projects and programs from study initiation to completion.

• Create and manage Data Management Plans, database specifications, edit check specifications, CCGs, and Data Transfer Agreements.

• Facilitate UAT, data cleaning, vendor reconciliation, progress metrics, and ensure timely database lock procedures.

• Oversee data management resources, timelines, scope, budgets, and risk management; escalate issues and keep leadership updated.

• Act as a representative for Data Management in both internal and external study meetings with sponsors and cross-functional teams.

• Function as a subject matter expert, offering guidance and training while addressing quality issues, conducting root cause analyses, implementing CAPAs, and updating guidance documents.

• Provide mentorship to Data Management colleagues and co-lead initiatives focused on departmental processes, quality, and efficiency.

• Assist in sponsor proposals and presentations, and contribute expertise during sponsor audits, regulatory inspections, and third-party meetings.

⛳️ Requirements

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related field, or equivalent relevant experience.

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

• Proficient knowledge of clinical data management best practices and technologies as they pertain to clinical trials.

• In-depth understanding of the clinical trial process and essential study documents, including protocols, statistical analysis plans, CRFs, and study reports.

• Capability to independently manage complex projects, troubleshoot issues, analyze problems, and maintain meticulous attention to detail.

• Outstanding written, verbal, interpersonal, and cross-functional communication skills.

• Proficiency in English.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable workplace.

• Equal employment opportunities.

• Opportunities for learning and growth.

• Mentoring and professional development through training.