Precision for Medicine
Healthcare
ClinicalDataManagerII/SeniorClinicalDataManager
“Clinical Data Manager II/Senior Clinical Data Manager at Precision for Medicine. Skills: Clinical data management, Database management, Data quality control. Manage clinical trial data management process. Oversee database development and testing”
What You'll Achieve.
Ensure deadlines are met with quality
Industry & Context.
Troubleshoot operational problems; Identify operational issues
Occasional travel
What They're Looking For.
Must Have
Bachelors and/or related experience, 8+ years Sr. Clinical Data Manager experience, 5 years Clinical Data Manager II experience, Proficiency in Microsoft Office, Excellent organizational skills, Excellent communication skills, Professional English written and oral, Experience with clinical database systems, Broad knowledge of drug/device/biologic development, Effective data management practices
Nice to Have
Experience in clinical, scientific or healthcare discipline, Dictionary medical coding experience, Understanding of CDISC standards, Oncology therapeutic experience, Orphan Drug therapeutic experience
What You'll Do.
Manage clinical trial data management process
Oversee database development and testing
Serve as Primary Data Management contact
Support another Lead DM
Oversee project data entry process
Develop data entry guidelines
Perform quality control of data entry
Assess and manage timelines
Meet clinical data management deadlines
Assess resource needs
Develop CRF specifications
Coordinate CRF specification review
Assist in building clinical databases
Conduct database build UAT
Maintain database build documentation
Oversee clinical database quality
Specify edit check requirements
Oversee edit check specification development
Create data management documentation
Revise data management documentation
Maintain data management documentation
Oversee documentation completeness for TMF
Train clinical research personnel
Review clinical trial data
Query clinical trial data
Perform line listing data review
Run patient status reporting
Run study status reporting
Perform medical coding
Coordinate SAE/AE reconciliation
Liaise with third-party vendors
Assist with SAS programming
Perform SAS program quality control
Identify operational problems
Troubleshoot operational issues
Provide feedback on protocols
Provide feedback on SAPs
Provide feedback on CSRs
Participate in SOP development
Participate in process documentation development
Attend strategy meetings
Attend bid defense prep meetings
Attend capability presentations
Attend client engagement meetings
Provide project estimates
Provide leadership for initiatives
Train data management team members
Ensure team members are trained
Communicate with study sponsors
Communicate with vendors
Communicate with project teams
Present software demonstrations
Present software trainings
Present department training sessions
Present company training sessions
Present at project meetings
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional teams; Project teams; Study sponsors; Vendors
Communication Scope
Oral communication; Written communication; Presentations
Process & Methodology
Timeline management, Resource assessment
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