Lead Data Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Serve as the lead data manager for one or more projects.

• Act as the main point of contact with the sponsor as needed and communicate with management regarding data management tasks.

• Oversee data management processes from database initiation through to database lock and CSR/submission.

• Function as the primary data management liaison for internal teams, sponsors, and third-party vendors.

• Ensure the delivery of high-quality data to sponsors.

• Collaborate with Project Managers to review revenue recognition workbooks upon completion of DM tasks.

• Develop and maintain Data Management Plans and essential data management documents in line with UBC SOPs.

• Contribute to study timelines, pinpoint risks, and communicate strategies for mitigation.

• Guarantee that data management deliverables are achieved punctually and coordinate data management efforts.

• Oversee cross-functional deliverables relating to data within study teams.

• Address and resolve data management challenges during study execution.

• Design and create specifications for database builds, which include CRFs/ePROs, visit/form configurations, and edit checks.

• Establish data cleaning requirements and assign data review tasks.

• Coordinate and engage in user acceptance testing of study databases and external vendor systems.

• Produce documentation and support Real World Evidence projects.

• Develop, monitor, analyze, and report on data management performance metrics.

• Supervise project budgets and inform project teams of possible change orders.

• Train and assist project-specific data management personnel.

• Contribute to the creation of Data Management SOPs, work instructions, templates, and standards.

• Engage in business development activities as needed.

• Carry out other responsibilities assigned by management.

⛳️ Requirements

• Bachelor's degree or equivalent experience in clinical data management.

• At least 5 years of experience in clinical data management.

• Proven leadership experience is essential.

• A client-focused approach is required.

• Experience across all phases of clinical trials within Data Management is preferred.

• Familiarity with late-stage and Real World Evidence projects is advantageous.

• Knowledge of Good Clinical Practices, clinical research, clinical trial processes, and associated regulatory requirements and terminology.

• Understanding of CDISC/CDASH standards, including the SDTM model.

• Exceptional written, interpersonal, and verbal communication abilities.

• Ability to work independently and report to the Manager of DM as necessary.

• Strong critical thinking and problem-solving skills.

• Willingness to travel up to 15%.

🏝️ Benefits

• Remote work opportunities available.

• Competitive salary packages.

• Opportunities for career advancement and promotion.

• 401K plan with company matching.*

• Tuition reimbursement options.

• Flexible work environment.

• Discretionary Paid Time Off (PTO).

• Paid holiday benefits.

• Employee assistance programs.

• Comprehensive Medical, Dental, and Vision coverage.

• Health Savings Account (HSA) and Flexible Spending Account (FSA) options.

• Telemedicine services (virtual doctor appointments).

• Wellness programs available.

• Adoption assistance programs.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance options.

• Various discount programs offered.