Job Description

　　Directs, plans, and coordinates clinical research program activities to ensure goals and objectives are accomplished within prescribed time-frame and funding parameters. Oversees program development and implementation as well as data collection and analysis; staff recruitment and management.

　　Job Responsibility

　　Leads a Clinical Research group by communicating with and developing staff members, and building consensus for programs and goals that support a business, function or geographic area.

　　Develops and articulates a short-term strategic vision for areas of responsibility.

　　Plans, directs and coordinates program activities to ensure goals and objectives are accomplished within prescribed time-frames and funding parameters; directs, oversees, and prioritizes daily activities of clinical trials staff.

　　Develops, implements, and oversees clinical trial activities including the development of final research protocols, data management and trial management plans.

　　Develops and integrates risk management plans to identify and address potential problems with program performance, timeliness and quality of results.

　　Directs staffing and resource planning and allocation across clinical trial projects; coordinates training, quality assurance and site evaluations.

　　Leads cross-functional integration of program components including site selection and supervision; coordination of site research staff with centralized rating partner as well as data management group.

　　Creates program budgets and forecasts for clinical research programs. Identifies, plans and participates in acquisition of funding.

　　Reviews and approves documents generated by clinical research including, but not limited to protocols, study reports and regulatory documents supporting Investigational New Drugs (INDs), New Drug Applications (NDAs) and Food and Drug Administration (FDA) information requests.

　　Directs regularly scheduled reporting to program executive leadership, sponsors, and program team; reviews quality assurance reports generated by the data management core and develops plans with sites for corrective actions, as needed.

　　Selects, develops, manages, and evaluates direct reports; oversees the development, management, and evaluation of indirect reports.

　　Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.

　　Job Qualification

　　Bachelor's Degree required, or equivalent combination of education and related experience. Master's Degree, preferred.

　　8-12 years of relevant experience and 7+ years of leadership / management experience, required.

　　Experience with Clinical Trials improvements preferred.

　　Experience with Clinical Trials management preferred.

　　Experience with Clinical Research preferred.

　　Experience with Regulatory affairs within academic center or hospital system preferred.

　　*Additional Salary Detail

　　The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).