Director of Clinical Operations, Biopharmaceuticals, Greensboro, NC

Accountable for the management of the Clinical Operations Department consisting of Clinical Research Coordinators, Clinical Research Coordinator Assistants and Research Associates as well as the Source Documentation Department. Responsible for Protocol Review and feasibility assessment. Responsible for project team assignments and training matrix implementation. Involved in site selection, study initiation and audit meetings. Responsible for conducting performance reviews and addressing work expectations to department members. Assist with developing department budget requirements as well as determining personnel and resource needs. Responsible for the development, maintenance and revision of SOPs and study specific procedures. Work with other departments to maintain project progress and issue resolution through weekly meetings and tracking tools. Plans, organizes, manages and monitors their sector's activities/operations according to their field of expertise, strategic and tactical alignments, and the needs of the organization in order to achieve the expected results. Ensures that revenues and budgetary margins are met in order to ensure the profitability of their division. Analyzes financial statements; controls expenses; makes recommendations; implements corrective actions. Establishes quality standards for their division and ensures that they are being adhered to. Ensures that studies are conducted within the required timeframes, according to the protocol. Establishes standards for customer service and ensures adhesion within the team. Ensures that team members adhere to the framework of ethical governance as well as all related standards, for volunteers. Manages human capital including workforce planning and hiring activities, performance management and daily monitoring of productivity; facilitates knowledge development and transfer; and ensures the efficiency and mobilization of the team in order to achieve the expected results. Establishes the organizational structure in order to achieve expected results. Through sound and innovative management, implements favorable conditions for optimal performance and development of their team members. Helps to develop their sector's performance indicator systems and the analysis of established objectives. Identifies opportunities for improvement in order to amend their division and/or service's master plan and processes. Determines, as needed, the necessary actions in order to streamline efficiency. Implements and ensures that practices, systems and value-added procedures are maintained. Implements and maintains a value-added work structure. Ensures harmonization between sites for practices, systems, procedures and the work organization. Contributes to the development of their sector's budget, ensures that it is being adhered to, performs budget follow-up for pertinent stakeholders and recommends actions in an effort to achieve the expected results. Communicates the necessary information to keep their team, the organization, and external clients abreast of their sector's work plan, policies, projects, processes, results, and actions and recommendations taken to meet arising needs and to achieve the expected results. Ensures client satisfaction by performing follow-up with team members for minor situations and by assuming responsibility of high-stake situations. Advises internal/external clients of their division and/or service's particular areas of expertise by assessing needs, and carrying out analysis and follow-up. Represents their sector, both internally and externally, as a source for consultation and/or information and/or reference. Provide strategic and tactical planning within Clinical Operations to achieve completion of projects on time and within budget Manage and direct daily activities of all Clinical Operations personnel to meet the company's objectives Plan and implement all components of Phase I clinical trials from study initiation through final integrated statistical study report Ensure Clinical Development teams have clear goals, objectives and milestones consistent with corporate objectives Maintain effective communication with senior management, so that they are aware at all times of critical issues confronting the projects and action plans that have been put in place Direct the growth and development of the Clinical Operations Department Hire, train, develop and manage all staff Initiate and manage clinical trials, resource projections and departmental budget Establish clinical operations infrastructure, including documentation, clinical trial management systems and clinical database platforms Manage all activities of staff Ensure all timeframes and targets are met on time and within budget Serve as a senior-level liaison with clients and support business development activities Oversee all aspects of study management
Requirements
Education: Master's degree in an appropriate discipline Professional experience: 8 to 15 years applicable work experience Well versed in ICH/GCP and applicable FDA regulations required Computer knowledge: Word, Excel Highly developed interpersonal and communication skills (written and oral) Strong leadership skills Please email your cover letter and resume to ruth@pharmacruiting.com About Pharma-Cruiting - Premier Recruitment of the Elite Pharma-Cruiting is a dynamic boutique executive recruitment firm specializing in the recruitment of mid and senior-level executives through C-Suite positions (e.g., CEO, COO, CFO) within the Life Sciences industries. We provide recruitment expertise in the most sought after areas, including (but not limited to) Pharmaceuticals, Biotechnology, Medical Devices, Diagnostics, Health, Genetics and Genomics throughout the United States. With over 15 years of industry experience, Pharma-Cruiting has achieved the level of expertise and experience necessary to successfully place elite executive talent giving companies a competitive edge and helping world-class professionals accomplish their dreams. We distinguish ourselves by "Recruiting only the Elite". Our accumulation of industry knowledge, expertise and extensive network of contacts has created sustained working relationships to enable us to create the perfect match for you. We deliver exceptional, strategic, comprehensive, and client-focused personalized services. Our strength is delivering the best and brightest talent aligned with your diversity and inclusion workforce goals. Professionalism, integrity, excellence in execution and customer satisfaction are our highest priority. Contact Pharma-Cruiting today for all of your recruitment needs: 215-485-2156 or email at info@pharmacruiting.com