Clinical Trial Manager -(V)

Job Summary:

• Oversees the direction, planning, execution, and interpretation of clinical trials/research and data collection activities.
• Establishes and approves scientific methods for the design and implementation of clinical protocols, data collection systems, and final reports.
• May recruit clinical investigators and negotiate study design and costs. Responsible for directing human clinical trials, phases I – IV, for company products under development.
• Responsibilities also include adverse event reporting and safety responsibilities monitoring.
• Coordinates and develops information for reports submitted to the Food and Drug Administration and the World Health Organization.
• Monitors adherence to protocols and determines study completion.
• May act as consultant/liaison with other corporations when working under licensing agreements.
• Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
• Performs all required management responsibilities including but not limited to: implementing the company’s policies, programs, and guidelines; ensuring employee productivity and growth; managing resources; knowing the company’s business; and maintaining functional, technical, and external market awareness necessary for managing an immediate organization.

Minimum Required Skills and Knowledge:

• Ability, competence, and confidence to lead people.
• Effective interpersonal skills.
• Other Desired Skills and Knowledge: Required Certifications and Training: Obtains and completes LMS training plan specific to assigned responsibility.
• Experience Level with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.
• Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired.
• Typical Education and Experience: Bachelor’s Degree or equivalent. 8 years of related experience. 3 years of management experience or supervisory equivalent.