Precision Medicine Group
Healthcare
ClinicalDataManagerII/SeniorClinicalDataManager
Neural analysis suggests this role is
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.
Ensure clinical data management deadlines met
Industry & Context.
Troubleshoot operational problems; Troubleshoot issues; Troubleshoot obstacles; Troubleshoot barriers
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, Set up and Database migrations experience, Proficiency in Microsoft Office, Excellent organizational skills, Excellent communication skills, Professional English written and oral, Utilizing various clinical database systems, Broad knowledge drug/device/biologic development, Effective data management practices, Representational skills, Ability to communicate effectively, Leadership skills, Interpersonal skills, Ability to undertake occasional travel
Nice to Have
Oncology experience preferred
What You'll Do.
Manage clinical trial data management process
Oversee database development
Perform database testing
Serve as Primary Data Management contact
Ensure task continuity and responsiveness
Support Lead DM as back-up
Oversee project data entry process
Develop data entry guidelines
Train personnel on data entry
Ensure data entry quality
Assess resource needs
Develop CRF specifications
Coordinate stakeholder feedback
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 data management documentation completeness
Train clinical research personnel
Review clinical trial data
Query clinical trial data
Perform line listing data review
Run patient status reporting
Run study level reporting
Perform medical coding
Ensure medical consistency
Coordinate SAE reconciliation
Coordinate AE reconciliation
Liaise with third-party vendors
Identify operational problems
Troubleshoot operational issues
Troubleshoot operational obstacles
Troubleshoot operational barriers
Provide feedback on protocols
Review Statistical Analysis Plans
Provide feedback on SAPs
Review Clinical Study Reports
Provide feedback on CSRs
Participate in SOP development
Participate in process documentation development
Maintain process documentation
Attend strategy meetings
Attend bid defense prep meetings
Attend capability presentations
Attend client engagement meetings
Review Request for Proposals
Provide project estimates
Provide leadership for initiatives
Train data management project 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 team members; Study sponsors; Vendors; Project teams
Communication Scope
Oral communication; Written communication; Presentations
Process & Methodology
Timeline management, Resource assessment, Project management
Full Job Description
We are hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our global team. We can consider candidates based in the UK, Poland, Hungary, Romania, Serbia or Slovakia. Position Summary: The Clinical Data Manager II/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. May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders 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. Trai
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