Senior Clinical Data Manager

Lightship; Virginia (MN); On-site; USD 120,000 - 170,000; Full time

Job summary

Lightship is seeking a Senior Clinical Data Manager to lead data management across one or more trials from start-up to closeout, ensuring data integrity per protocol, ICH-GCP, and company SOPs. You will collaborate with Clinical Operations, Biostatistics, Safety, Sponsors, CROs and vendors.

The role emphasizes data design, quality management, and database lock readiness, with responsibilities spanning CRF/eCRF design, UAT, data reconciliation, and cross-functional leadership in decentralized and

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• 7+ years of clinical data management experience.
• Experience with decentralized and digital trials preferred.
• Strong knowledge of CDISC SDTM and regulatory standards.

Responsibilities

• Lead end-to-end data management for assigned studies.
• Design CRF/eCRF and review database specifications.
• Coordinate data cleaning, reconciliation, and query management.
• Support regulatory inspections and sponsor reviews.

Skills

Clinical Data Management

Study Leadership

Decentralized Trials

Vendor Collaboration

Education

Bachelor's degree Life Sciences

Advanced degree preferred

Tools

Medrio

Medidata Rave

Veeva Vault CDMS

Oracle InForm

Job description

The Senior Clinical Data Manager is responsible for leading all data management activities across one or more clinical trials from study start-up through database lock and study closeout. This role ensures the collection, validation, integrity, and quality of clinical trial data in compliance with protocol requirements, ICH-GCP guidelines, regulatory standards, and company SOPs. The Senior Clinical Data Manager serves as the primary data management lead for assigned studies and collaborates closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Sponsors, CRO partners, and technology vendors.

Key Responsibilities

Study Management & Oversight

• Lead end-to-end clinical data management activities for assigned studies.
• Develop and maintain Data Management Plans (DMPs), Data Validation Plans, and study-specific data review strategies.
• Participate in protocol review to ensure data collection requirements support study endpoints and operational execution.
• Provide data management leadership during study start-up, conduct, database lock, and study closeout activities.
• Serve as the primary point of contact for sponsor and cross-functional data management discussions.

Database Design & Development

• Lead CRF/eCRF design and review to ensure accurate and efficient data collection.
• Collaborate with EDC developers to build, test, and validate study databases.
• Review database specifications, edit checks, derivations, and integration requirements.
• Oversee User Acceptance Testing (UAT) and ensure all study requirements are met prior to go-live.
• Design workflows supporting virtual, hybrid, and decentralized study models.

Data Review & Quality Management

• Develop and implement data cleaning and review strategies.
• Perform ongoing data review to identify trends, inconsistencies, and quality concerns.
• Lead query management activities and ensure timely query resolution.
• Review protocol deviations, missing data, and key risk indicators impacting data quality.
• Monitor data quality metrics and provide regular status reporting.
• Oversee integration and reconciliation of external data sources including, but not limited to:
  • Central laboratories
  • ePRO/eCOA systems
  • Wearable devices and digital health technologies
  • Safety databases
• Ensure timely receipt, validation, and reconciliation of external datasets.
• Coordinate with vendors to resolve data discrepancies and integration issues.

Database Lock & Study Closeout

• Lead database lock planning and execution.
• Facilitate data review meetings and lock readiness assessments.
• Ensure all reconciliation activities are completed prior to lock.
• Coordinate final data transfer to Biostatistics and other stakeholders.
• Support regulatory inspections, audits, and sponsor reviews.

Cross-Functional Collaboration

• Partner effectively with Clinical Operations, Medical Monitoring, Safety, Vendors, and Sponsors.
• Contribute pragmatic data management solutions that balance startup speed, operational feasibility, quality, and budget considerations.

Additional responsibilities, as assigned.

Qualifications

Education

• Bachelor's degree in Life Sciences, Clinical Research, Health Informatics, Biostatistics, Computer Science, or related field required.
• Advanced degree preferred.

Experience

• 7+ years of clinical data management experience in biotechnology, pharmaceutical, CRO, or clinical research environments.
• Experience leading data management activities for Phase I-IV clinical trials.
• Experience with decentralized, hybrid, or digital clinical trials preferred.
• Prior sponsor-facing leadership experience strongly preferred.

Technical Skills

• Proficiency with EDC systems such as Medrio, Medidata Rave, Veeva Vault CDMS, Oracle InForm, or equivalent.
• Strong understanding of CDISC standards, including SDTM and controlled terminology.
• Experience with external data integrations and reconciliation processes.
• Experience participating in study startup activities, including protocol review, data collection strategy development, and EDC implementation
• Knowledge of clinical trial regulations, including ICH-GCP, FDA, EMA, and applicable global requirements.
• Advanced Microsoft Excel and reporting capabilities.
• Strong project management and organizational skills.
• Excellent analytical and problem-solving abilities.
• Exceptional attention to detail and commitment to data quality.
• Ability to manage multiple studies and competing priorities simultaneously.
• Strong communication and stakeholder management skills.
• Ability to work independently in a fast-paced environment.

Preferred Experience for Decentralized Clinical Trials

• Experience overseeing data from remote and virtual trial technologies.
• Experience with diagnostic-device or diagnostic-assay clinical studies preferred.
• Familiarity with participant-centric data collection methodologies.
• Experience supporting geographically dispersed research sites and mobile research teams.

Success Measures

• Timely database builds and study start-up deliverables.
• Achievement of database lock timelines.
• High-quality, audit-ready clinical data.
• Reduction in data query aging and resolution timelines.
• Strong sponsor satisfaction and stakeholder engagement.
• Successful management of multiple concurrent studies while maintaining quality standards.
• Successful management and reconciliation of internal and external clinical data sources while maintaining data quality and inspection readiness.