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UBC

Patients First. Powered by Evidence.

Lead Data Manager

Data ScientistData ScientistFull TimeRemoteSeniorTeam 1,001-5,000Since 2003H1B No SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

44 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Lead Data Manager

UBC

• 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. • Ensure data management deliverables are met on time. • 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 the 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. • 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.

Job Requirements

  • 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

  • At UBC, employee growth and well-being are always at the forefront.
  • We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.
  • Here are some of the exciting perks UBC offers:
  • 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

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