Senior Clinical Data Manager

Accountabilities • Lead assigned clinical data management studies independently, overseeing databases and data management activities throughout the full study lifecycle.

• Serve as the primary liaison for sponsor and internal data management interactions, maintaining strong communication and alignment across global study teams.

• Monitor study timelines, deliverables, quality standards, and data management performance to ensure projects remain on track.

• Oversee and/or develop key data management documentation, including Data Management Plans, eCRF completion guidelines, CRFs, help text, validation specifications, and testing plans.

• Lead or support database design, user-role configuration, edit checks, internal system testing, user acceptance testing, database changes, and implementation activities.

• Oversee data review, quality control, query management, vendor data reconciliation, exception reporting, and overall data consistency and accuracy.

• Identify data issues and trends, communicate findings to study teams and sponsors, and support the development and implementation of corrective action plans.

• Develop and maintain data management reports, metrics, listings, reconciliations, and custom reporting requirements in collaboration with programming teams.

• Coordinate database freeze and lock activities and ensure all associated study documentation and requirements are completed.

• Delegate responsibilities, provide guidance to study team members, mentor junior colleagues, and support effective workload planning across projects.

• Participate in study kickoff, closeout, lessons learned, investigator meetings, sponsor and site training, proposal defenses, and other client-facing activities as required.

• Contribute to SOPs, work instructions, training materials, process improvements, and initiatives that enhance the efficiency and consistency of clinical data management.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Biotechnology, or another health-related field; an advanced degree is preferred.

• 8+ years of professional experience in clinical data management, preferably within a CRO, pharmaceutical, biotechnology, or related life sciences environment.

• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and applicable clinical data management standards.

• Demonstrated experience with EDC systems and clinical data management platforms, including database setup, data review, validation, cleaning, and reconciliation activities.

• Strong project management and study leadership capabilities, including work planning, delegation, prioritization, and oversight of multiple stakeholders.

• Experience working with clinical trial databases, external data sources, edit checks, queries, data validation specifications, and database freeze/lock processes.

• Strong analytical skills with the ability to identify data trends, investigate issues, and translate findings into practical actions.

• Excellent written and verbal communication skills, with confidence engaging sponsors, global study teams, investigators, and internal stakeholders.

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

• Strong organizational skills and attention to detail, with the ability to manage competing priorities while maintaining high-quality deliverables.

• A collaborative, proactive approach with the ability to work independently, provide guidance to colleagues, and contribute to continuous process improvement.

Benefits

• Competitive U.S. salary range of $110,000–$130,000 USD .

• Opportunity to work remotely in a flexible, people-first environment.

• Exposure to innovative clinical data management technology and centralized data analytics.

• Opportunity to work on clinical development initiatives with life sciences organizations and global study teams.

• Career development opportunities within a fast-growing organization focused on innovation and continuous learning.

• Inclusive culture that values diverse perspectives, collaboration, professional growth, and work-life balance.

• Recognition as a 2025 Top Workplaces USA Award recipient for remote work and multiple culture excellence awards.

• Equal opportunity employment environment committed to qualifications, merit, and inclusive hiring practices.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1