Lead Data Manager

Remote from: USA
Annual salary: Undisclosed
Salary information is not provided for this position. Check our Salary Directory to estimate the average compensation for similar roles.
Department: Data Science & Analytics
Employment type: Full Time,
Job posted: 15 Jul 2025
Apply before: 15 Aug 2025
Experience level: Senior
Views / Applies: 12345 / 123

About company

About PSI CRO

Predictable patient enrollment across multiple therapeutic areas.

Pharmaceuticals
1995

Actively Hiring

Company Description

We’re over 2,700+ strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way.

You are dynamic. You are curious. You are more than your job. For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we’re looking for.

Job Description

The Lead Data Manager is responsible for all data management activities in assigned clinical trials under supervision.

Acts as primary communication point for project teams and company departments regarding clinical data management
Acts as primary communication point for clients/vendors for all data management aspects of clinical projects
Coordinates data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables
Provides input into monitoring of project scope, budget, timelines, and deliverables
Is responsible for clinical data management activities including, but not limited to:
- Development of study documentation (eCRF Requirements, Edit Checks Specification, Data Management Plan, CRF Completion Guidelines, User Access Management Plan, Data Validation Plan, External Data Transfer Agreements, SAE Reconciliation Guidelines, Local Lab Normal Ranges Guidelines, Coding Guidelines where applicable)
- User acceptance testing
- User access management
- Data review
- eCRF/External data reconciliation
- Medical coding (for staff with medical/Life Science background)
- SAE reconciliation
- Query management
- Study Database Lock activities
- Archival of CRFs QC Coordination
- Project status reporting
- Data listings/Patient profiles generation
Maintains and QCs TMF/eTMF as well as Data Management working files
Trains Data Managers and Assistant Data Manager
Conducts project-specific training

Qualifications

College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities
Minimum of three years of industry experience in Data Management
Two years in Data Manager role
This role requires travel on an as needed basis for client presentations, bid defense meetings, department meetings, and the like.