Senior Clinical Data Manager

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

📋 Description

• Take the initiative as the study lead for designated clinical trial projects.

• Supervise, uphold, and manage clinical trial databases throughout the entire data management lifecycle.

• Act as the main point of contact between eClinical Solutions and the sponsor's team.

• Design and oversee database specifications, validation processes, maintenance/data cleaning, and finalization tasks.

• Track study timelines and deliverables effectively.

• Ensure the overall quality, efficiency, and consistency of data management operations.

• Engage with global study teams for effective communication.

• Take part in kickoff, closeout, and lessons-learned meetings.

• Develop and present materials for Investigator Meetings.

• Create and provide training for Sponsor CRAs and/or site personnel.

• Assign tasks and lead study data management teams.

• Manage or produce data management documents, IST plans, testing, UAT packages, data reviews, QC checks, vendor reconciliations, queries, reports, metrics, and specifications.

• Monitor issues until resolution and identify data discrepancies or trends.

• Keep study documentation up-to-date and conduct database freeze/lock procedures.

• Engage in process enhancement, SOP/WI/training material creation, mentoring, proposal defenses, and other tasks as requested by management.

⛳️ Requirements

• A Bachelor’s degree in Pharmaceutical/Biotechnology or a higher qualification in a health-related field is preferred.

• Over 8 years of experience in Clinical Data Management is preferred.

• Familiarity with ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.

• Strong project management capability and leadership skills in project teams, including planning and task delegation.

• Experience utilizing EDC and conducting data management activities.

• Exceptional verbal and written communication abilities.

• Proficiency in Microsoft Office Applications, particularly MS Project and MS Excel.

• Experience with EDC and Clinical Data Management Systems.

🏝️ Benefits

• Opportunity for remote work.

• Professional development and growth opportunities for your career.

• Support for work-life balance.

• An inclusive workplace culture.

• Commitment to equal opportunity employment.