Clinical Data Manager

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

📋 Description

• Independently lead data management activities across multiple complex global projects and programs from the initiation phase through execution, database lock, and project closure.

• Strategically plan resources, timelines, budgets, scope, and risks, while appropriately escalating any concerns.

• Create and supervise Data Management Plans, specifications for databases and edit checks, completion guidelines, data transfer agreements, and vendor reconciliation specifications.

• Drive user acceptance testing, data cleaning, reconciliation, metrics reporting, and activities related to database locking.

• Collaborate with sponsors and internal cross-functional teams, effectively representing Data Management in study meetings.

• Act as a subject matter expert by providing guidance, training, and maintaining process documentation.

• Lead responses to quality issues related to processes, including conducting root cause analyses and implementing corrective and preventive actions.

• Mentor colleagues in Data Management and actively contribute to initiatives focused on departmental processes, quality, and efficiency.

• Assist with business development proposals and presentations for sponsors.

• Engage in sponsor audits, inspections by regulatory authorities, and other third-party 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 7 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device sectors.

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

• Advanced comprehension of the clinical trial process and essential documents, including protocols, statistical analysis plans, CRFs, and study reports.

• Strong independent leadership capabilities, along with analytical and problem-solving skills.

• Exceptional attention to detail.

• Outstanding communication and interpersonal abilities.

• Proficiency in English, with robust written and verbal communication skills.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable workplace.

• Equal employment opportunities.

• Transparent compensation and pay equity.