Lead Clinical Data Manager

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

📋 Description

• Act as the main Data Management resource for one or more clinical studies from the initiation phase to database lock and close-out.

• Coordinate Data Management tasks with sponsors, CROs, and cross-functional teams.

• Manage database setup and design, Database UAT, query management, data cleaning, and reconciliation of third-party data.

• Create and maintain Data Management Plans, Data Review Plans, CRF completion guidelines, data review guidelines, medical coding guidelines, and data transfer agreements.

• Supervise CRO and EDC vendor performance and deliverables.

• Assist in vendor selection, risk assessment, timeline and resource planning, and escalation of issues.

• Represent Data Management on project teams, working groups, investigator meetings, and during inspections and audits by sponsors or health authorities.

• Ensure adherence to data standards and CDISC conventions, including CDASH and SDTM.

• Contribute to initiatives for process improvement, SOPs, and Work Instructions.

• Ensure compliance with SOPs, Work Instructions, ICH-GCP, and relevant regulations.

• Lead, mentor, and ensure timely delivery of high-quality outputs.

⛳️ Requirements

• BA/BS degree in a scientific discipline, nursing, business, or information systems.

• 7–10+ years of experience in clinical data management, including experience on the sponsor and/or CRO side.

• Advanced proficiency with EDC systems; experience with Medidata Rave is preferred.

• Proven experience in overseeing the performance and deliverables of CRO and EDC vendors.

• Strong understanding of FDA regulations, ICH guidelines, Good Clinical Practice, and HIPAA.

• Experience in oncology and familiarity with RECIST/RANO response criteria.

• Excellent skills in communication, organization, and cross-functional collaboration.

• Willingness to travel approximately 10%, or as required for essential business activities.

• Experience in supporting health authority inspections or audits is a plus.

• Experience with Phase III pivotal studies is preferred.

• Working knowledge of SAS or other programming/reporting tools such as Excel, Spotfire, or Python is preferred.

🏝️ Benefits

• Company-paid healthcare.

• Flexible spending accounts.

• Voluntary life insurance.

• 401K matching.

• Uncapped vacation.

• Onsite gym.

• Dining at the facility.