Site Manager

Responsibilities

• Coordinate the review of all new clinical research protocols as they relate to the clinical and business feasibility aspects of conducting the study.
• Represent the company to pharmaceutical companies and physicians in a professional business manner.
• Work with new business development team in timely review and completion of new study feasibility queries.
• Work with budgets and contracts team in development of new studies, approving final budgets.
• Develop and maintain relationships with affiliate physicians, coordinating activities to ensure affiliate sites are functional, efficient, and cost effective.
• Responsible for day-to-day financial activities including monitoring and approval of accounts payable invoices and assist in tracking of accounts receivable.
• Coordinate end of month accounting activities with finance team.
• Completion and submission of weekly Operational Reports.
• Provide support and supervision of the patient recruitment department, coordinating the design and implementation of patient recruitment programs.
• Provide support and supervision for the regulatory affairs department ensuring 100 percent compliance with all federal regulations, sponsor protocols, and internal/external standard operating procedures.
• Provide support and supervision for the computer systems/database management department.
• Work with Clinical Research Coordinators and other site staff to ensure efficient operations through a proactive teamwork environment.
• Schedule employees to ensure company business activities are conducted to meet customer expectations and satisfaction.
• Ensure fair, equitable and consistent administration of all corporate and company policies.
• Coordinate personnel and payroll activities with Human Resources as required in a timely and efficient manner.
• Work with Clinical Research Coordinators to assess clinical and administrative staffing needs, including cost benefit analysis.
• Facilitate communication between administrative, patient recruitment and clinical staff to ensure study development, site initiation, patient enrollment and study documents are completed to meet sponsor/contract obligations.
• Provide administrative support to Clinical Staff as needed.

Skills and Qualifications

Education and experience: Bachelor's degree in business/marketing or related field or equivalent professional level of experience. 5 years of business operations or in a business, medical office environment, clinical trial, or research environment, working with children.

Requirements

• Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
• Knowledgeable in medical terminology
• Self-directed with the ability to respond to problems with professionalism and flexibility.
• Progressive management style with established supervisory abilities.
• Experience in computerized bookkeeping systems.
• Knowledge of GCPs, FDA regulations, quality assurance and pharmaceutical industry desirable.
• Excellent interpersonal skills, written and oral communication skills.
• Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)