Precision for Medicine
Healthcare
ClinicalDataManagerII/SeniorClinicalDataManager
Neural analysis suggests this role is
optimal for Senior candidates.
“Clinical Data Manager II/Senior Clinical Data Manager at Precision for Medicine. Skills: Clinical data management, Database build, Data management documentation. Manage clinical trial data management process. Oversee database development”
Industry & Context.
Troubleshoot operational problems
Occasional travel
What They're Looking For.
Must Have
8+ years experience as Sr. Clinical Data Manager, 5+ years experience as Clinical Data Manager II, Bachelors and/or related experience, Proficiency in Microsoft Office, Excellent organizational skills, Excellent communication skills, Professional use of English
Nice to Have
Oncology experience preferred, PhD preferred, Cloud platform certs
What You'll Do.
Manage clinical trial data management process
Oversee database development
Oversee database testing
Serve as Primary Data Management contact
Ensure task performance in a timely manner
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 review
Conduct database build UAT
Maintain database build documentation
Oversee clinical database quality
Specify edit check requirements
Oversee edit check development
Oversee manual data review 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
Perform medical coding
Ensure medical consistency
Coordinate SAE reconciliation
Coordinate AE reconciliation
Liaise with third-party vendors
Support vendor timelines
Support vendor deliverables
Assist with SAS programming
Quality control SAS programs
Identify operational problems
Troubleshoot operational issues
Troubleshoot obstacles
Troubleshoot barriers
Provide feedback on protocols
Provide feedback on SAP
Provide feedback on CSR
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
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
Written communication; Oral communication
Process & Methodology
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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