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Clinical Data Manager II
Precision For Medicine. Manage all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects under some supervision .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management, including proficiency in database management systems and adherence to CDISC standards. Strong organizational and communication skills are essential for managing clinical trial processes and liaising with stakeholders.
Highest-signal resume keywords
Clinical Data ManagementDatabase Management System ProficiencyCDISC Standards UnderstandingMedical Coding KnowledgeOncology Therapeutic Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data EntryQuality ControlCRF Specification DevelopmentSAS ProgrammingData ReviewMetric ReportingTrial Master File ManagementDatabase Build DocumentationEdit Check SpecificationMedical Logic Consistency
Soft Skills
Excellent Organizational SkillsStrong Communication Skills
Tools & Technologies
Microsoft OfficeElectronic Data Capture (EDC)Clinical Trial Management Software
Industry Keywords
Clinical TrialsDrug DevelopmentBiologic DevelopmentMedDRAWHODrugCDASHSDTMADaM
About the role
Key responsibilities & impact- Manage all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects under some supervision
- Serve as primary Data Management contact or contributor for assigned clinical projects/programs, ensuring continuity, responsiveness, and timely task completion
- Perform data entry and quality control for paper-CRF studies as needed
- Provide input into timelines, ensure clinical data management deadlines are met with quality, and assess resource needs as needed
- Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback
- Assist in building clinical databases
- Conduct database build UAT and maintain quality-controlled database build documentation
- Oversee overall clinical database quality
- Specify requirements for electronic, manual data review, and other edit checks
- Create, revise, version, and maintain data management documentation and oversee Trial Master File completeness
- Train clinical research personnel and project team members on study-specific CRFs, EDC, and related items
- Review and query clinical trial data according to the Data Management Plan
- Perform line-listing data review and patient- and study-level status and metric reporting
- Perform medical coding of medical terms to ensure medical logic and consistency
- Coordinate SAE/AE reconciliation
- Liaise with third-party data and EDC vendors in a project manager capacity
- Assist with SAS programming and quality control of SAS programs
- Identify and troubleshoot operational problems using metrics data, audit reports, and stakeholder input
- Review and provide feedback on protocols, SAPs, and CSRs when required
- Participate in developing and maintaining SOPs and process documentation
- Attend strategy meetings, bid defense preparation, capability presentations, and potential client engagement meetings as needed
- Review RFPs, proposals, and provide project estimates as needed
- Communicate with sponsors, vendors, and project teams regarding data, database, and project issues
- Present software demonstrations, trainings, and project meetings as needed
- Perform other assigned duties
Requirements
What you’ll need- Bachelor’s degree and/or a combination of related experience
- 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Able to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Must be able to read, write, speak fluently and comprehend the English language
- Experience in utilizing a clinical database management system
- Broad knowledge of drug, device and/or biologic development and effective data management practices
- Ability to undertake occasional travel
- Understanding of dictionary medical coding (MedDRA and WHODrug) preferred
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) preferred
- Oncology therapeutic experience preferred
- Candidates must be legally authorized to work in the country of employment without employer sponsorship
Benefits
Comp & perks- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
- Potential occasional travel opportunities