Associate Director, Clinical Data Management

Oversees and manages all aspects of data management operations including staffing and staff development, project resource planning/loading, project management, leading/supporting the implementation of strategies to improve efficiencies, sponsor support, and assuring quality work execution and output. Actively participates in business development and strategic planning. Applies a high level of technical expertise and professional experience to effectively lead data management and clinical programming staff and to develop solution alternatives to problems. Keeps Executive Management apprised of data management project status. Maintains performance metrics that are adequately analyzed for trends, the root cause(s), and corrective action(s). This can be a remote role for people living on the East Coast.

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 manage department and clinical study budgets
• .Liaise with internal and external cross-functional teams, sponsors, vendors, etc.
• Serve as a lead clinical data manager on clinical studies, as needed, as much as 25% time
• Participate in proposal and contract writing and negotiation
• Reviews/writes/updates standard operating procedures (SOP’s) and work instructions 
• Actively works to continuously improve data management operations to reduce cost and timelines and to improve quality
• Develop, maintain, analyze, and report on department performance metrics
• Develop and conduct in-house training

Requirements

• Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11
• Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating, and resource management skills
• Effective leadership, budget forecast, and implementation skills
• Skills including programming and medical coding (adverse events, medical history, and medical therapies) are a plus
• CDISC CDASH/SDTM training and experience
• Expert EDC knowledge in Rave (iMedNet is a plus)
• Experience in multiple therapeutic areas (TAs) in clinical trials including experience in at least two of the following TAs: oncology and infectious disease

Education or Equivalent Experience

• Bachelor’s degree in applied or life science and a minimum of 8 years of experience in clinical trials (with at least 6 years in data management) or equivalent education and work experience.
• Advanced degree and direct supervisory experience preferred.

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