Lead Data Manager

United-Biosource-Corporation; King of Prussia (PA); Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities for promotion

401K with company match*

Flexible work environment

Discretionary PTO (Paid Time Off)

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Job summary

United-Biosource-Corporation (UBC) is seeking a Lead Data Manager in King of Prussia, PA to act as lead data manager for one or more projects and serve as the primary contact with the sponsor for data management activities. This role involves developing the Data Management Plan, coordinating with DM teams, and ensuring quality data delivery.

You will oversee DM deliverables from database start-up to lock, collaborate with internal, sponsor and vendor teams, and contribute to risk assessment and

Qualifications

• BS/BA degree or equivalent in clinical data experience.
• Minimum 5 years clinical data management experience.
• Leadership experience required.
• 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.
• Willingness to travel up to 15%.

Responsibilities

• Lead data management activities on assigned studies 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.
• Deliver high-quality data to sponsors and ensure client satisfaction.
• Review revenue recognition workbooks with Project Managers when DM tasks are completed to secure payments.
• Develop and maintain the Data Management Plan and core DM documents per UBC SOPs.
• Provide input on study timelines, risks and mitigation strategies.

Skills

Leadership experience

Client-focused approach

Clinical data management

Regulatory knowledge

CDISC/CDASH/SDTM familiarity

Written and verbal communication

Independent work

Critical thinking

Travel up to 15%

Study timelines & risk management

Education

BS/BA Degree or equivalent in clinical data experience

Tools

CDISC/CDASH/SDTM standards

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Lead Data Manager

Regular Research & Clinical King of Prussia, PA, US

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%

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
• Growth opportunities for promotion
• 401K with company match*
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance

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.