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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical data management, including the development and maintenance of Data Management Plans, adherence to Good Clinical Practices, and effective communication with sponsors and project teams. Proven ability to lead data management activities, ensure quality data delivery, and manage project timelines and budgets.
Highest-signal resume keywords
Clinical Data ManagementLeadership ExperienceGood Clinical PracticesCDISC/CDASH FamiliarityReal World Evidence Projects
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 Management Plan DevelopmentDatabase Build SpecificationsData Cleaning RequirementsUser Acceptance Testing (UAT)Data Review PlansRevenue RecognitionMetrics ReportingRisk IdentificationProject Budget ManagementClinical Trial Process
Soft Skills
Client-Focused ApproachExcellent Communication SkillsCritical ThinkingProblem-SolvingInterpersonal Skills
Certifications & Qualifications
BS/BA Degree
Industry Keywords
Clinical TrialsRegulatory RequirementsSDTM ModelData Management OperationsFeasibility Questionnaire
About the role
Key responsibilities & impact- Act as a lead data manager for one or more projects
- Act as primary contact with the sponsor as required and communicate with management regarding all data management activities within their studies
- Accountable for data management activities on assigned study projects from database start-up through database lock and CSR/submission
- Serve as the primary data management contact for internal, sponsor and 3rd party vendor teams
- Responsible for delivering quality data to the sponsors
- Responsible for reviewing the revenue recognition workbooks with the Project Manager(s) when DM tasks are completed for each month/phase of the project to ensure client payments
- Create and maintain the Data Management Plan and all other core DM documents (e.g., data review plans, data transfer plans, coding guidelines, CRF completion guidelines, database finalization and freeze/lock, etc.) for assigned projects and ensure they follow UBC SOPs
- Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager
- With oversight, ensure data management deliverables are met on time
- Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities
- Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables
- Provide solutions for data management issues that arise during study conduct
- Design and develop database build specifications (i.e., CRFs/ePROs, Visit/form configuration specifications, edit check specifications) to meet study data requirements per protocol
- Develop data cleaning requirements for assigned projects
- Distribute data review tasks to the data management team on the project
- Coordinate and participate in all user acceptance testing (UAT) activities of study databases and external vendor systems
- Develop documents and support Real World Evidence Projects (e.g., Feasibility Questionnaire, Variable Gap)
- Develop, track, analyse and report, as applicable, on data management performance metrics from study start to database lock and provide to project managers, sponsors, etc.
- Responsible for adhering to project budgets and notifying project teams of the need for potential change order
- Responsible for the training and support of project-specific DM staff on all data management operations and documents (e.g., CRFs/PROs/COAs/RWE designs, protocol, data cleaning process/query resolution) on an ongoing basis
- Provide input during the development and/or review of Data Management SOPs, Work Instructions and templates/standards incorporating the industry's best practices and any applicable Regulatory guidelines and requirements
- Participate in business development activities as required.
- Other duties as assigned by management
Requirements
What you’ll need- BS/BA Degree or equivalency in clinical data experience
- Minimum 5 years clinical data management experience
- Leadership experience required
- Client-focused approach to work
- Experienced in all stages of clinical trials within Data Management is preferred
- Experience in late stage and real-world evidence projects a plus
- Understand Good Clinical Practices, Clinical research, Clinical Trial process and related regulatory requirements and terminology
- Familiarity with CDISC/CDASH including the SDTM model
- Excellent written, interpersonal, and verbal communication skills
- Work independently and report to the Manager of DM, as appropriate
- Critical thinking and problem-solving
- Willingness to travel up to 15%
Benefits
Comp & perks- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs