Sr. Manager, Clinical Data Management

Oversees and manages all aspects of data management operations including staffing and resourcing, project management, operations management and client management. Applies a high level of technical expertise to effectively lead all data management.

Primary Responsibilities

• Oversee day-to-day data management operations
• Serve as subject matter expert during client and vendor meetings
• Actively support business development in capabilities presentations to prospective and current clients
• Effectively provides input for department and clinical study budgets
• Liaise with internal and external cross-functional teams, sponsors, vendors, etc. • Serve as project manager on clinical studies, as needed
• Work closely with Director of Data Management, Managers of Data Management, Clinical Data Managers and Clinical Data Analyst to mentor data management staff
• Ensure project work is planned, resource allocated and is successfully executed
• Provide direction to staff when issues arise that the staff cannot resolve on their own
• Ensure proper training and development of staff
• Conduct regular meetings and completes year-end performance reviews with all direct reports
• Monitor performance of team and initiate process and resource improvement in partnership with Director of Data Management

Requirements

• Articulate and professional • Extensive experience in Clinical research
• Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
• Strong project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating, and resource management skills
• Effective leadership, budget forecast, and implementation skills
• EDC experience in multiple EDC systems including Medidata Rave preferred • May Require Travel up to 20%
• Four (4) years of experience direct management of personnel is required
• Clinical Research experience in a CRO setting preferred; CDISC SDTM training and experience are preferred.

Education or Equivalent Experience

• Master’s degree (preferably in engineering, applied or life science) and at least seven (7) years of experience in clinical data management including leading several clinical studies

OR

• Bachelor’s degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of eight (8) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and nine (9) years of experience in a clinical trial.

Benefits

What you can expect from us:

• Competitive wages
• Flexible work schedules
• Fully remote roles
• Variety of therapeutic areas
• Career advancements
• Medical insurance
• HSA with company match
• Dental with 2 coverage options
• Vision
• 401K with company match
• Paid Time off
• Over 10 company holidays
• Life Insurance
• Inclusive and collaborative company culture
• Identity theft protection
• Voluntary accident and critical illness insurance