Clinical Data Management Director
4 days ago
Statistics & Data Corporation (SDC), a specialized contract research organization (CRO), is seeking a highly skilled Clinical Data Management Director to oversee and manage all aspects of Data Management Operations.
Key Responsibilities:
- Oversee day-to-day data management operations, ensuring on-time and quality deliverables and excellent client service and satisfaction.
- Manage one or more key accounts and studies; interface with the client to address feedback, ensure risks and issues are resolved.
- Serve as subject matter expert during client and vendor meetings.
- Lead teams located globally to deliver all aspects in Data Management, including the Database build processes.
- Perform independent review or quality review of all team deliverables prior to sending to client.
- Perform all client communications across the DM functions; face to face, teleconferences, and emails for lead role tasks.
- Perform internal escalations, project status updates, and project management functions, including updates to PM systems.
- Actively support business development in capabilities presentations to prospective and current clients.
- Effectively provide 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, 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, actively manage performance, and complete 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.
- Adhere to all aspects of the company's quality system.
- Comply with the company's data integrity and business ethics requirements.
Requirements:
- Articulate and professional.
- Extensive experience in clinical research and Data Management in multiple therapeutic areas.
- Electronic Data Capturing (EDC) RAVE experience.
- 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.
- May require travel up to 20%.
Education or Equivalent Experience:
- Master's degree (preferably in Engineering, Applied or Life Science) and at least three (3) years of experience in Clinical Data Management, including leading several clinical studies, or a Bachelor's degree (preferably in Engineering, Applied or Life Science) with a minimum of five (5) years in DM.
- One year of experience in direct management of personnel.
- Clinical research in a CRO setting is preferred.
Why SDC:
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.
Our Culture:
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.
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