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

📋 Description

• Spearhead comprehensive data management initiatives across various intricate global projects and programs, from initiation to database locking and conclusion.

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

• Supervise User Acceptance Testing (UAT), data cleansing, external vendor reconciliation specifications, and database locking processes.

• Allocate resources while monitoring project scope, budgets, timelines, risks, and performance metrics, escalating issues as necessary.

• Act as the representative for Data Management in internal, sponsor, and study meetings.

• Work collaboratively with cross-functional teams and Data Management leadership to address and resolve challenges.

• Lead and contribute to evaluations and enhancements of processes.

• Educate, assist, and guide Data Management team members.

• Engage in sponsor audits, regulatory authority inspections, and other external meetings as required.

⛳️ Requirements

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

• At least 5 years of experience in clinical data management or a comparable role within the pharmaceutical, biotechnology, or medical device sectors.

• Comprehensive knowledge of best practices in clinical data management and technologies employed in clinical trials.

• Strong grasp of clinical trial processes and essential study documents, including protocols, statistical analysis plans, CRFs, and study reports.

• Demonstrated capability to independently manage projects, prioritize tasks, and resolve complex issues with meticulous attention to detail.

• Exceptional communication and interpersonal skills, with the ability to work effectively with both internal and external cross-functional teams.

• Proficiency in English.