Clinical Data Manager - Boston, United States - Bayside Solutions

Bayside Solutions Boston, United States

3 weeks ago

Pharmaceutical / Bio-tech

Description

Clinical Data Manager

Direct Hire Full-Time Role

Salary Range: $130,000 - $150,000 per year

Location: Boston, MA - Hybrid or Remote

Duties and Responsibilities:

You will develop and maintain study-specific documentation and manage clinical data.
Create Data Management Plans, eCRF specifications, CRF Completion Guidelines, and Data Validation Guidelines.
Produce Data Transfer Specifications, Coding Guidelines, a Post-Production Database, Change Control Documentation, Database Audits, and Lock Procedures.
Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules.
Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming.
Work with database programmers to design (e)CRFs and edit checks in the EDC system for complex studies.
Coordinate with Sponsors and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation.
Troubleshoot technical issues.
Design listings and study-specific processes for effective data review, query issues, and resolution.
Manage queries and trends to ensure data completeness and integrity.
Perform coding of adverse events, medical conditions, and medications.
Perform SAE reconciliation.
Lead and perform pre-lock and data lock tasks.
Prepare training materials and user guides for EDC data collection tools; deliver user training.
Participate in client and team meetings as required, providing status updates and advising on best practices as appropriate.
Design, generate, and review status metric reports, identifying and communicating trends as needed.
Ensure the archival of study databases and related documents.
Organize and file study documentation.
Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies.
Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes.
Provide study-specific training for team members and end users.
Implement technical solutions and new tools and resolve complex issues.
Lead large and complex projects.
Lead client and team meetings as required.
Delegate tasks as appropriate, providing mentorship and following through completion.
Interact with sponsors and manage vendors for complex studies.
Assist with the identification of project scope changes.
Present at sales and marketing meetings for prospective clients.
Develop SOPs and manuals.

Requirements and Qualifications:

9+ years of experience in Clinical Data Management
BS in a scientific or health-related field
Knowledge of medical terminology and notation
Expertise with EDC systems, including Medidata Rave, InForm, and Medrio
Excellent organizational and time management skills
Strong collaboration and leadership skills

Desired Skills and Experience

Clinical Data Management, eCRF, UAT, EDC, Medidata Rave, InForm, Medrio

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