[Hiring] Associate Director, Global Clinical Study Management @NAMSA

Role Description

• Provides leadership and management direction to the Clinical Operations function.
• Build effective working relationships with both internal and external partners; may act as a Strategic Partner with key clients.
• Assists direct reports in developing effective strategies for communicating with and motivating project team members.
• Intervenes and problem-solves with challenging clients as necessary.
• Participate in resource planning to ensure project deliverables and client goals are met; ensure Associates are assigned clinical projects that are appropriate for their skills and training.
• Accomplish clinical department financial objectives by forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
• Confirm appropriate regulations and quality are applied within study and site management activities supported by NAMSA.
• Work with staff to ensure client expectations are met including the schedule, cost and quality of our services. May lead projects, as needed, to meet key milestones, deliverables, or organizational goals.
• Maintain qualified staff by recruiting, selecting, orienting, and training Associates and Managers.
• Provide training and development opportunities to direct staff via personal development plans, quality oversight/assurance and/or career path planning.
• May act as business owner for one or more NAMSA Clinical applications (e.g. CTMS, eTMF).
• Lead continuous process improvement initiatives to drive efficiency and innovation within the Clinical organization.
• Support review of proposals and provide input as needed.
• Participates in meetings with prospective clients.
• Identifies opportunities to bring in new projects/clients.
• Offers opportunities to clients for expansion of Clinical services to be provided by NAMSA.
• May represent the company and its capabilities at professional meetings, congresses, and other industry events.
• Travel as required inside and outside of the U.S.

Qualifications

• Master’s degree or Bachelor’s degree and equivalent experience in a related field.
• Minimum of 8 years of relevant experience including 3 years of management experience.
• Knowledge of Good Clinical Practices and other regulations which apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial oversight accordingly.
• Familiarity with all aspects of the clinical trial process including, but not limited to protocol development, site selection/qualification, site initiation, monitoring, close-out, investigator meetings, DSMB/CEC, core lab management, and site compliance escalation.
• Multidiscipline (at least 2 specialties) therapeutic knowledge.
• Familiarity with medical device development process from pre-clinical to commercialization.
• Understanding of the role of data management and biostatistics in the clinical trial process.
• Understanding of the type and quality of data needed from a clinical trial and how it should be presented.
• Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC personnel, and clients (and persuade them to do what is needed).
• Ability to participate in and present during an FDA/notified body/regulatory inspection.
• Strong management and strategic business mindset and skills.
• Ability to provide work direction, to include organizing, prioritizing, negotiating, communicating relevant project information and scheduling work assignments.
• Ability to handle multiple priorities and issues, foster a cooperative work environment with high quality standards, and facilitate and manage effective meetings.

Working Conditions

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.