Senior Site Director
Scottsdale, AZ, USA | Imaging Endpoint
Industry:Pharmaceutical / Biotech
Job Description:55 people have viewed this job
The Senior Site Director position provides leadership and oversight to the Site Management Organization (SMO) within Imaging Endpoints. This position will take the lead role in managing the day-to-day operations of the SMO, as well as a strategic role in creating and implementing a robust clinical trials program. This position will also oversee and coordinate the operational aspects of ongoing projects to ensure corporate goals of time, cost and quality performance expectations are met.
• Establish a strategic vision and long-range plan for the Site Management Organization.
• Responsible for accountability and the site’s Profit and Loss.
• Assists Senior Leadership in the development and preparation of the site’s research budget and is responsible for the execution of that budget.
• Liaison with the Accounting Department to assist in the preparation of Profit Margin and Monthly Revenue Reports.
• Analyze and evaluate the study activities, while maintaining metrics on costs, operations, budgets and forecast data to determine site progress towards stated study goals and objectives.
• Takes accountability for the site’s financial performance and continually seeks out improvements to enhance the overall business.
• Provides the site staff with expertise and guidance on recruitment and enrollment of the clinical trials to ensure site(s) profitability.
• Serves as a business development liaison with the pharmaceutical industry for pipeline clinical trials.
• Is proactively participating in quality reviews and works collegially with the internal Compliance Department in implementing the appropriate changes that lead to corrective actions.
• Must be able to develop an overall business plan and metrics to assure full recruitment of studies.
• Serves as liaison with third-party vendors for budgets and contracts.
• Provides guidance and training to the clinical research coordinators and assistants to ensure staff has proper oversight, leadership, and guidance in the management and execution of trials.
• Provides training and mentoring to site staff and the Investigator and serves as the onsite leader and exemplifies the core values of the organization.
• Functions as the organization’s liaison to the physician and physician practice to ensure the appropriate Investigator oversight is maintained.
• On a limited basis, may need to function as a Clinical Research Coordinator to help support revenues and decrease operational costs.
• Select, coach and mentor all site staff to ensure they possess the necessary knowledge and skills to achieve quality and revenue objectives.
• Develop and maintain effective leadership and working relationships with all site personnel in accordance with the Company’s policies and procedures.
• Conduct weekly site meetings with Senior Leadership and staff to communicate information, provide continuing education, training and enhance teamwork.
• Develop succession and training plans for all direct reports and assist or conduct annual performance appraisals.
• Make decisions on selecting and managing staff as well as external vendors.
• Analyze collected data to identify patterns and trends for opportunities to improve client care/service performance.
• Monitor and ensure site compliance with company policies and procedures, quality assurance guidelines and all federal, state and local laws.
EDUCATION AND EXPERIENCE
• BA/BS required; Master’s strongly preferred, and a minimum of 7 years of Clinical Research Site Management experience running clinical trials and managing teams.
• Must have significant experience managing Phase I-IV trials Pharmaceutical Trials.
• Minimum of 3 years of Clinical Research Coordinator experience.
• Experience with Clinical Trial Management Systems.
• Central IRB Regulatory Experience required.
• Strong knowledge of FDA regulations, IRB requirement, and Good Clinical Practices is required.
• Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications.
• Exceptional organizational skills, attention to detail and follow through.
• Excellent verbal and written communication skills.
• Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers.
• Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads.
• Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
• Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other confidential information.
• Must be a strong leader, set the example and willing to mentor others.
• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
• Estimated up to 10% travel (domestic and international)
Imaging Endpoints is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status
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