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 sponsors and liaise with management regarding study data management activities.

• 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 delivery of high-quality data to sponsors.

• Review revenue recognition workbooks with Project Managers upon completion of DM tasks.

• Create and sustain Data Management Plans and essential data management documentation.

• Provide insights on study timelines, identify potential risks, and communicate strategies for mitigation.

• Coordinate data management deliverables and activities of cross-functional study teams.

• Address and resolve data management challenges encountered during the study.

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

• Establish data cleaning requirements and distribute tasks for data review.

• Organize and engage in user acceptance testing of study databases and systems from external vendors.

• Produce documents and support Real World Evidence projects.

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

• Comply with project budgets and inform project teams about any potential change orders.

• Train and assist project-specific data management personnel.

• Contribute to the formulation of Data Management SOPs, work instructions, templates, standards, and regulatory best practices.

• Engage in business development activities as needed.

• Carry out additional duties as assigned by management.

⛳️ Requirements

• BS/BA Degree or equivalent clinical data experience.

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

• Leadership experience is a must.

• A client-focused approach to work is essential.

• Preferred experience in all phases of clinical trials within Data Management.

• Experience in 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 is required.

• Familiarity with CDISC/CDASH and the SDTM model is preferred.

• Exceptional written, interpersonal, and verbal communication skills are necessary.

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

• Strong critical thinking and problem-solving skills.

• Willingness to travel up to 15%.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching.*

• Tuition reimbursement programs.

• Flexible working environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision insurance.

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

• Telemedicine services (virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance benefits.

• Discount programs available.