Senior Remote Clinical Data Manager & EDC Lead

Hart Clinical Consultants; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Hart Clinical Consultants is seeking a Clinical Data Manager - Project Manager to lead data management for full study lifecycles in a remote US-based role. You will design CRFs, establish EDC timelines, and collaborate with sponsors to ensure compliant data handling.

Responsibilities include leading UAT, monitoring KPIs, maintaining DM documents, delivering EDC training, and coordinating with vendors and cross-functional teams across trials.

Qualifications

• Minimum of 10 years of clinical data management experience, including at least 5 years serving as Lead Data Manager.
• Strong knowledge of EDC systems (iMednet, Medrio).
• Working knowledge of GCP, GCDMP, and ICH guidelines.
• Understanding of CDASH/CDISC standards.
• Experience in clinical data management within a pharmaceutical, medical device, or CRO environment.

Responsibilities

• Lead all data management activities across the full study lifecycle.
• Design CRFs based on the study protocol and collaborate with cross-functional team members and sponsor to finalize and obtain approval.
• Develop database requirements specifications, including visit schedules, edit checks, user roles and permissions, email alerts, and subject status definitions.
• Establish EDC build and go-live timelines in partnership with the database developer and provide support throughout the build process.
• Lead EDC User Acceptance Testing (UAT), including authoring test scripts, coordinating sponsor and cross-functional participation, and documenting findings.
• Oversee internal validation activities prior to system go-live.
• Present weekly data metrics at internal project team meetings and sponsor calls.
• Monitor KPIs on a quarterly basis and develop mitigation plans when performance is at risk.
• Develop and maintain core data management documentation, including the Data Management Plan, eCRF Completion Guidelines, Data Review Guidelines, and Coding Plan.
• Deliver study-specific EDC training for internal team members, sponsors, and sites, as needed.
• Perform ongoing data review, issue and track queries within the EDC system, and communicate data issues to internal stakeholders.
• Manage EDC access for all users, including granting and revoking permissions as appropriate.
• Establish and maintain timelines for data management deliverables throughout each project.
• Serve as the primary data management point of contact for sponsors.
• Conduct impact assessments for mid-study updates and manage related documentation and testing activities.
• Participate in audits as assigned.
• Contribute to departmental process improvement initiatives.

Skills

EDC systems knowledge (iMednet, Medrio

Project management

Cross-functional collaboration

Regulatory knowledge (GCP, ICH)

Data management excellence

Education

Bachelor's degree in life science, nursing, computer science, or related discipline

Tools

iMednet

Medrio

Job description

Hart Clinical Consultants is seeking a Clinical Data Manager - Project Manager to lead data management for full study lifecycles in a remote US-based role. You will design CRFs, establish EDC timelines, and collaborate with sponsors to ensure compliant data handling.

Responsibilities include leading UAT, monitoring KPIs, maintaining DM documents, delivering EDC training, and coordinating with vendors and cross-functional teams across trials.