・Manages and provides leadership to Clinical Operations Staff, including the supervision of more senior level clinical operations management positions in the assigned Business Unit and region.
・Analyzes resourcing capacity and ensures a consistent quality of services and balanced work team.
・Assures clinical operations delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures.
・Liaise with other departments and business units to establish harmonized clinical operations practices, processes and tools.
・Participates in the financial review of project status and drives project financial performance, particularly as related to clinical operations services.
・Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required.
・Extensive knowledge of ICH/GCP guidelines and other applicable regulatory requirement
・Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas, and ability to work across those functional areas. Ability to understand, explain and communicate project concepts and put into detailed plans.
・Demonstrated strong leadership, tactical and strategic thinking skills. Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner. Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.
・Demonstrated ability to self-direct tasks and set direction and priorities for others to achieve departmental goals.
・Strong time management, technical, and organizational skills
・Must demonstrate proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to gain working knowledge in other applicable business tools and systems.
・Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both
written and spoken, with an ability to inform, influence, convince, and persuade. ・Ability to travel as necessary (approximately 20%)