Lead Data Manager

United Biosource Corporation•King of Prussia, PA

13h•Remote

About The Position

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! This role acts as a lead data manager for one or more projects, serving as the primary contact with the sponsor as required and communicating with management regarding all data management activities within their studies.

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.
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%.

Nice To Haves

Experienced in all stages of clinical trials within Data Management is preferred.
Experience in late stage and real-world evidence projects a plus.

Responsibilities

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 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.