Lead Data Manager

UBC; United States; On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

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)

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Discount programs

Job summary

UBC is seeking a Manager, Data Management to lead data management activities across studies from start-up through database lock and CSR/submission. You will act as the primary DM contact for sponsors and vendor teams, delivering high-quality data and ensuring timelines and budgets are met.

The role requires leadership experience, 5+ years in clinical data management, and familiarity with CDISC standards. Remote opportunities exist alongside a collaborative, growth-oriented environment.

Qualifications

• BS/BA degree or equivalent in clinical data experience.
• Minimum 5 years clinical data management experience.
• Leadership experience required.
• Understanding of GCP and regulatory guidelines.
• Familiarity with CDISC standards (CDISC/CDASH, SDTM).

Responsibilities

• Lead data management on one or more projects from start-up to database lock and CSR/submission.
• Serve as primary DM contact for sponsor, internal teams and vendors.
• Deliver quality data to sponsors.
• Review revenue recognition with Project Managers when DM tasks are completed.
• Create and maintain the Data Management Plan and core DM documents.
• Provide input on study timelines, risks, and mitigation strategies to PM.
• Ensure DM deliverables are met on time and coordinate cross-functional teams.
• Design and develop CRF/ePRO and data configuration specifications.
• Develop data cleaning requirements for projects.
• Coordinate UAT for study databases and external systems.
• Develop and report DM performance metrics.
• Monitor budgets and notify PMs of potential changes.
• Train DM staff on DM operations and documents.
• Contribute to SOPs and templates; support regulatory requirements.
• Participate in business development activities.
• Other duties as assigned.

Skills

Leadership

Client-focused

Communication

Independent work

Critical thinking

Travel up to 15%

Education

BS/BA Degree or equivalency in clinical data experience

Tools

CDISC/CDASH/SDTM

Job description

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Job Title: YBI01H - Manager, Data Management

Brief 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.

Specific Job Duties

• 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 3 rd 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 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 (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.

Supervisory Responsibility

N/A

Desired Skills And 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

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

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.