Senior Director, Clinical Data Management

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry.

This person will oversee and manages some aspects of data management operations related to the assigned team structure including staffing and staff development, oversight of management team members, project resource planning/loading, project management, leading/supporting 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, root cause(s) and corrective action(s).

Why SDC

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

• Oversee day-to-day data management operations for assigned teams
• Ensure operational excellence (employee development, on-time and quality-based deliverables) and client
• service excellence
• Able to promote, demonstrate and mentor team in regard to vision, mission, core values and Quality First
• Serve as subject matter expert during client and vendor meetings
• Actively support business development in capabilities presentations to prospective and current clients
• Effectively manage clinical study budgets and change management processes
• Works with leadership team for department level strategic planning
• Facilitate the collaboration with internal and external cross-functional teams, sponsors, vendors, etc.
• Participate and provide feedback in proposal, contract writing, budget templates/algorithms creation 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
• Ensure corporate and quality compliance of study teams
• Provide input to department budget
• Develop and conduct in-house training

Requirements

• Extensive experience in clinical data management preferably within a CRO environment
• Successful record of accomplishment in establishing, directing, and overseeing data management operations
• division/department
• Demonstrated ability to successfully manage compressed study timelines and staff/team members and in
• accordance with applicable regulations
• 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, negoti