Work Authorization: Candidates must be currently authorized to work in the United States. At this time, the client is unable to provide visa sponsorship, visa transfer, immigration filings, or employer-paid immigration support for this role.
Title: Lead Clinical Data Manager / Project Lead Data Manager
Company: Massachusetts-based CRO
Employment Type: Full-Time, Permanent
Location: Fully Remote – U.S.; Eastern Time Zone preferred
Salary: Approximately $130,000–$150,000
Start Date: ASAP
Position Overview
A Massachusetts-based CRO is seeking an experienced, hands-on Lead Clinical Data Manager to independently lead Data Management activities for a large, complex Phase 3, double-blind global clinical study with 100+ investigative sites.
The ideal candidate will combine strong study leadership with hands-on Clinical Data Management expertise and be comfortable working directly with sponsors, CROs, vendors, and cross-functional teams.
Key Responsibilities
• Serve as a primary Data Management contact for sponsors and vendors.
• Lead sponsor meetings, study updates, risk discussions, issue resolution, and action-item follow-up.
• Lead and perform data cleaning, query management, reconciliation, listings review, database maintenance, and database lock activities.
• Manage database amendments, including requirements gathering, review, UAT coordination/tracking, and implementation.
• Lead cross-functional data review meetings with Clinical Operations, Biostatistics, Programming, Medical Monitoring, and other stakeholders.
• Monitor CRO/vendor deliverables, timelines, data quality, and compliance.
• Provide leadership and guidance to other Data Management team members.
• Proactively identify issues and drive solutions with minimal supervision.
• Ensure Data Management activities are performed in accordance with ICH/GCP principles and applicable study requirements.
Required Qualifications
• Significant hands-on Clinical Data Management experience.
• Experience independently leading complex clinical studies, preferably global Phase 3 trials.
• Strong sponsor-facing and stakeholder-management experience.
• CRO and external vendor oversight experience.
• Experience with database maintenance, amendments, UAT, reconciliation, data cleaning, listings, query management, and database lock.
• Strong practical knowledge of ICH/GCP.
• Excellent communication, organization, and problem-solving skills.
• Ability to independently manage priorities and drive study activities forward.
Preferred Qualifications
• Prior direct experience working for a CRO is highly preferred.
• Experience supporting large global studies involving approximately 100+ sites.
• Experience managing mature studies during the active conduct phase.
• Experience partnering with clinical CROs and cross-functional study teams.
• Previous leadership or supervision of Data Management professionals.
• Zelta EDC experience preferred; experience with other major EDC platforms will also be considered.
Study Environment
The initial assignment is a large Phase 3 global study that has been underway for more than three years. The database has already been built, with current activities focused on ongoing data review, database maintenance and amendments, reconciliation, site closures, data cleaning, listings, and study oversight.
The position requires someone who can become productive quickly, remain hands-on, communicate effectively with sponsors and stakeholders, and independently lead complex Data Management activities.
Work Authorization
Candidates must be authorized to work in the United States under an arrangement that does not require employer-provided H-1B transfer sponsorship or associated costs. H-1B sponsorship and transfer costs are not provided for this position.
Pay: $130,000.00 - $150,000.00 per year
Benefits:
• 401(k)
• Dental insurance
• Health insurance
• Vision insurance
Work Location: Remote