[Hiring] Associate Director, Global Clinical Study Management @reputed company

This description is a summary of our understanding of the job description. Click on 'Apply' reputed company to find out more. 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/reputed company; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
• Confirm appropriate regulations and quality are applied reputed company study and site management activities supported by reputed company.
• Work with staff to ensure client expectations are met including the schedule, cost and quality of our services. May reputed company projects, as needed, to meet key milestones, deliverables, or organizational goals.
• Maintain reputed company staff by reputed company, selecting, orienting, and training Associates and Managers.
• Provide training and development opportunities to direct staff reputed company personal development plans, quality reputed company/assurance and/or career path planning.
• May act as business reputed company for one or more reputed company Clinical applications (e.g. CTMS, eTMF).
• reputed company reputed company process improvement initiatives to drive efficiency and innovation reputed company 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 reputed company.
• May represent the company and its capabilities at professional meetings, congresses, and other industry events.
• Travel as required inside and reputed company of the U.S.

Qualifications

• Master’s degree or Bachelor’s degree and equivalent experience in a reputed company 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 reputed company accordingly.
• Familiarity with reputed company aspects of the clinical trial process including, but not limited to protocol development, site selection/qualification, site initiation, monitoring, reputed company-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/reputed company body/regulatory inspection.
• Strong management and strategic business reputed company 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 reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company 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 reputed company with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific reputed company abilities required by this job include reputed company reputed company, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.

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