Data Management Lead

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

📋 Description

• Delivers technical expertise in all facets of Data Management.

• Acts as the main point of contact for Data Management on assigned studies.

• Ensures that contractual Data Management commitments are fulfilled with an emphasis on quality and punctuality.

• Oversees the timelines for study data delivery, which includes Go-Live, Interim Deliveries, and Final Database Lock.

• Works collaboratively with cross-functional teams across various global locations.

• May offer mentorship to Assistant Data Managers and colleagues within Data Management.

• Evaluates and interprets study metrics to identify trends and provide insights on study health.

• Reviews agreements to effectively manage sponsor-specific metrics and performance indicators.

• Participates in cross-functional meetings and documents meeting minutes and action items.

• Ensures adherence to Standard Operating Procedures and ICH/GCP guidelines.

• Identifies quality concerns, ensuring they are addressed and resolved appropriately.

• Engages in internal, sponsor, and regulatory audits and inspections.

⛳️ Requirements

• A minimum of 6 years of hands-on experience in Clinical Data Management.

• Demonstrated experience in leading project and program teams.

• Solid understanding of project tools, reports, and processes related to project financial management, including forecasting, revenue recognition, scope of work, and departmental budgets.

• Good knowledge of Clinical Study Team roles outside of Data Management.

• Extensive knowledge and application of ICH-GCP guidelines, local regulatory requirements, Standard Operating Procedures, and study-specific protocols.

• Familiarity with SDTM, CDISC, and CDASH standards.

• Strong technical skills with Clinical Trial/Data Management Systems such as InForm, Rave, Veeva, DataLabs, and Microsoft Office applications.

• Proficient in both written and spoken English.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Remote work options.