Precision Medicine Group
ClinicalDataManagerII/SeniorClinicalDataManager
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optimal for Senior candidates.
“Clinical Data Manager II/Senior Clinical Data Manager at Precision Medicine Group. Skills: Clinical data management, Database management, Data quality control. Manage clinical trial data management process. Oversee database development”
What You'll Achieve.
Meet deadlines with quality
Industry & Context.
Troubleshoot operational problems
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, English proficiency (written and oral)
Nice to Have
PhD preferred, 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
Oversee database testing
Serve as Primary Data Management contact
Ensure task continuity and responsiveness
Support another Lead DM
Oversee project data entry process
Develop data entry guidelines
Manage data entry quality
Assess resource needs
Develop CRF specifications
Coordinate CRF specification review
Build clinical databases
Conduct database build UAT
Maintain database build documentation
Oversee clinical database quality
Specify edit check requirements
Oversee edit check specification development
Oversee manual data review specification development
Create data management documentation
Revise data management documentation
Version data management documentation
Maintain data management documentation
Oversee documentation completeness for TMF
Train personnel on CRF
Train personnel on EDC
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 reconciliation
Coordinate AE reconciliation
Liaise with third-party vendors
Assist with SAS programming
Perform SAS programming quality control
Identify operational problems
Troubleshoot operational issues
Troubleshoot operational obstacles
Troubleshoot operational barriers
Provide feedback on protocols
Provide feedback on SAP
Provide feedback on CSRs
Participate in SOP development
Participate in SOP maintenance
Participate in process documentation development
Participate in process documentation maintenance
Attend strategy meetings
Attend bid defense prep meetings
Attend capability presentations
Attend potential client engagement meetings
Provide project estimates
Provide leadership for initiatives
Train data management team members
Ensure team member training
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
Process & Methodology
Project management
Full Job Description
*This position is 100% remote, but the preference is to have someone on the east coast* Position Summary: The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e. g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related
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