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Manager, Clinical Data Management
3 months ago
Manager, 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.
Job Summary
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 tasks.
Primary Responsibilities
• Oversees day-to-day data management operations
• Serves as subject matter expert during client and vendor meetings
• Actively supports business development in capabilities presentations to prospective and current clients
• Effectively provides input for department and clinical study budgets
• Liaises with internal and external cross-functional teams, sponsors, vendors, etc.
• Serves as Project Manager on clinical studies, as needed
• Works closely with Director of Data Management, Clinical Data Managers and Clinical Data Analyst to mentor data management staff
• Ensures project work is planned, resource allocated and is successfully executed
• Provides direction to staff when issues arise that the staff cannot resolve on their own
• Ensures proper training and development of staff
• Conducts regular meetings and completes year-end performance reviews with all direct reports
• Monitors performance of team and initiates process and resource improvement in partnership with Director of Data Management
• Adheres to all aspects of the company’s quality system
• Complies with the company’s data integrity and business ethics requirements
• Performs other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requirements
Required Skills
•Articulate and professional
•Extensive experience in Clinical research and Data Management in multiple therapeutic areas
•Electronic Data Capturing (EDC) experience; experience utilizing Medidata Rave a strong plus
•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 five (5) years of experience in Clinical Data Management including leading several clinical studies, or a Bachelor’s degree (preferably in Engineering, Applied or Life Science) or equivalent education and work experience with a minimum of six (6) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and six (6) years of experience in clinical trial.
•Two (2) years of experience direct management of personnel is preferred.
•Clinical research in a CRO setting and CDISC SDTM training is preferred.
Benefits
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
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