Lead Data Manager

🕒 4 days ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

👻 Ghost score 10%

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 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 data management activities • Manage data management activities from database start-up through database lock and CSR/submission • Serve as primary data management contact for internal, sponsor, and third-party vendor teams • Deliver quality data to sponsors • Review revenue recognition workbooks with Project Managers when DM tasks are completed • Create and maintain Data Management Plans and core data management documents in accordance with UBC SOPs • Provide input on study timelines, identify risks, and communicate mitigation strategies • Ensure data management deliverables are met on time and coordinate data management activities • Coordinate cross-functional study team deliverables affecting data • Resolve data management issues during study conduct • Design and develop database build specifications, including CRFs/ePROs, visit/form configurations, and edit checks • Develop data cleaning requirements and distribute data review tasks • Coordinate and participate in user acceptance testing of study databases and external vendor systems • Develop documents and support Real World Evidence projects • Develop, track, analyze, and report data management performance metrics • Monitor project budgets and notify project teams of potential change orders • Train and support project-specific data management staff • Contribute to Data Management SOPs, work instructions, templates, and standards • Participate in business development activities as required • Perform other duties assigned by management

🎯 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

• 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