Associate Director, Clinical Operations, CNS
Develop Life-changing CNS Therapies for Patients with Unmet Medical Needs
Contribute to a Global Leader in Clinical Research
- Top 3 global CRO with approximately 25,000 employees world-wide
- Provides leadership, direction and management to Clinical Operations staff within CNS.
- Provides training, consultation and oversees quality related for operating activities of assigned staff to ensure project deliverables are met.
- Acts as primary point of contact for resourcing escalations, assuring utilization, performance and development of Clinical Operations staff.
- May liaise with other departments or business units to optimize resources as well as to establish harmonize clinical operations practices, processes and tools. Contributes to operational initiatives.
- Line Management of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counselling of staff, including the management and development of other Clinical Operations line managers.
- Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
- Oversee a portfolio or program of projects within CNS
- Ensure all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
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 and experience with GCP/ICH guidelines and other applicable regulations.
Demonstrate strong leadership, tactical and strategic thinking skills. Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas. Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.
Ability to understand, explain and communicate project concepts and put into detailed plans. Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.
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.
- Act as Japan clinical lead and intermediary between Japan CO and global