Manager, Clinical Data Management

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Oversee management and leadership for designated Data Management teams and projects related to study execution and budget administration.

• Serve as the main point of contact for internal and external escalations specific to each study.

• Represent the organization in sponsor governance meetings.

• Assign staff to projects based on their skills and competencies.

• Provide oversight, training, mentoring, and opportunities for career growth.

• Ensure projects are well-resourced and that operational or budgetary risks are addressed.

• Handle performance-related escalations concerning team members.

• Notify Data Management leadership of upcoming availability to ensure continuity of utilization.

• Assist Business Development in preparing proposals and sponsor presentations.

• Engage in sponsor audits, inspections by regulatory authorities, and meetings with third parties.

• Act as a Subject Matter Expert for designated Data Management processes as needed.

• Evaluate and enhance process effectiveness and efficiency.

• Provide training related to processes and serve as the primary contact for inquiries.

• Manage quality issues, including conducting root-cause analyses and CAPAs as necessary.

• Maintain and refresh QMDs and other relevant guidance documents.

• Mentor members within the Data Management department.

• Lead initiatives aimed at improving departmental processes and efficiency.

• Carry out additional duties as assigned.

⛳️ Requirements

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

• At least 9 years of experience in clinical data management or a similar position within the pharmaceutical, biotechnology, or medical device sectors.

• 2–4 years of experience in line management.

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

• Advanced understanding of clinical trial processes and protocol documentation, including protocols, statistical analysis plans, CRFs, and study reports.

• Strong project management capabilities and experience overseeing data management teams and projects concerning operational and budget oversight.

• Experience in line management, including recruitment, career development, and performance evaluations.

• Exceptional attention to detail.

• Outstanding written and verbal communication skills.

• Excellent communication and interpersonal abilities for collaboration with both internal and external cross-functional teams.

• Independent analytical and problem-solving capabilities.

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation and pay equity.