Title: Director, Clinical Operations, Medical Device/ Pharma/SkinCare
Location: Roswell GA (http://bit.ly/Roswell-Green)
Function: Quality Assurance/Regulatory
Reports to: VP Clinical Affairs/Operations, Kimberly-Clark Corporation
Kimberly-Clark in the Healthcare Environment
Around the world, medical professionals turn to Kimberly-Clark (NYSE:KMB) for a wide portfolio of solutions that improve the health, hygiene and well-being of their patients and staff. As part of their healing mission, caregivers rely on Kimberly-Clark to deliver clinical solutions and educational resources that they can depend on to prevent, diagnose and manage a wide variety of healthcare-associated infections. This more than $1 billion global enterprise of Kimberly-Clark Corporation holds the No. 1 or No. 2 market share position in several categories, including infection control solutions, surgical solutions, pain management and digestive health. And throughout the care continuum, patients and staff alike trust Kimberly-Clark medical supplies and devices, KLEENEX tissues, Kimberly-Clark Professional skin care products and SCOTT towels for day-to-day needs. For more information, visit http://www.kchealthcare.com.
Direct a team to provide services including global business plan development, mergers & acquisitions, Health Care strategy and deployment, and operational excellence (a shared services platform consisting of Sales & Marketing Effectiveness and Business Process & Continuous Improvement)
• Oversees management of multiple, concurrent clinical studies through external clinical research organizations (CROs) and internal Project Managers and Clinical Research Associates (CRAs)
• Initiates, designs, plans, and manages clinical projects according to applicable regulations, SOPs (standard operating procedures) and internal guidelines for human subject testing within agreed time frames and budgets
• Identifies, recommends, and implements solutions for current clinical programs that are not meeting objectives
• Responsible for the department budget
• Responsible for clinical study project management across the enterprise, inclusive of:
• Study protocol
• CRO management
• Monitoring oversight
• Clinical data management
• Site qualification, training and monitoring
• Participate in the preparation of regulatory documents for submission to FDA and other regulatory agencies including agencies including but not limited to 510k submissions
Interested? Or perhaps you know of someone that might be, you can apply directly using this link: http://bit.ly/14952-ClinOpsDir and it will be reviewed within several work days.
• Bachelors of Science Degree with 7+ years in the device industry that includes a minimum three years direct clinical research/development engagement
• Experience working in a global or similarly structured organization
• Experience in the development and design of study protocols and all related documentation
• Experience in coaching and mentoring at managerial and/or supervisory level
• Experience in the coordination, compilation and analysis of outcomes data across all protocols in a given project, and in preparation of clinical summaries for submission to the FDA and other regulatory authorities.
• Strong experience with device (IDE’s and studies that have led to PMA and/or PMA supplement application and/or approvals) clinical studies
• Business communication skills (e.g., verbal, written, presentation); both external and internal
• Responsible for providing input and oversight of vendor and contractor selection and management
• Experience with the participation in cross-functional teams required
• Advanced Degree (MBA, MS, or PhD).
• Global level clinical trial experience preferred.