Senior Data Manager
Remote, REMOTE, United States
PSI CRO
PSI is a leading full-service global Contract Research Organization. Predictable patient enrollment across multiple therapeutic areas.Company Description
We’re over 2,300+ 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 Senior Data Manager is responsible for supervision of all data management activities in clinical projects or clinical programs and may perform data management activities in clinical projects.
- Acts as a communication point for project teams and company departments regarding clinical data management depending on the study role
- Acts as a communication point for clients for all data management aspects of clinical projects and clinical data management reporting depending on the study role
- Is responsible for the supervision of all project data management activities in the assigned studies
- Monitors project scope, budget, timelines, and deliverables
- Reviews/approves study documentation including but not limited to 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
- Participates in Vendor management on project level
- May perform clinical data management activities depending on the assigned study role
- Maintains and QCs TMF/eTMF and Data Management working files
- Prepares for and attends internal and third-party study and systems audits
- Conducts project-specific training of the clinical team in CRF completion and presents at the Investigator Meetings
- Trains Operations staff in Clinical Data Management
- Provides input into proposals (Data Management aspects)
- Prepares and attends Bid Defense Meetings
- Participates in process improvement and vendor management activities at a corporate/departmental level
Qualifications
- College or University degree or equivalent combination of training and experience that presents the required knowledge, skills, and abilities
- Minimum of seven years of industry experience in Data Management
- Four years in Principal/Lead Data Manager role
Additional Information
All your information will be kept confidential according to EEO guidelines.
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Data management
Perks/benefits: Career development
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