Lead Data Manager

Role Description

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.
• DM Project Management: 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.

Qualifications

• 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

• 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.