Manage team/directs and overall activities for the Regulatory and Start-Up (RSU) component of designated projects within the country, region or function, in accordance with the scope of work and contracted timelines in line with RSU portion of the study budget. Ensure the operational integration of department goals and objectives.
? Provide Proposal Management with input on proposals and budget development for RSU component of projects. Attend proposal defenses as needed.
? Where applicable, review and ensure project instructions for RSU projects are complete and accurate, including local requirements as appropriate. Provide feedback to employees in the writing of project work instructions.
? Resource employees efficiently to ensure achievement of utilization and realization targets.
? Review and analyze performance metrics and processes to provide input in the development and implementation of process/system improvements.
? Accountable for employee efficiency and adherence to standard operating procedures (SOPs), work instructions, and project instructions and timelines.
? Manage employees in accordance with organization’s policies and applicable laws. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions for all management / human resource matters.
? Mentor employee and ensure adherence to project timelines, scope of work and budget.
? Serve as lead for single projects or programs as necessary.
? Serve as advisor for designated clients as necessary. Provide RSU oversight across protocols / programs. Serve as point of contact for issue escalation and process alignment.
? Participate in the selection and on-boarding process for new RSU employees by conducting candidate review and participating in the interview process. Ensure employees have the appropriate materials, systems access and training to complete job responsibilities.
? Support team to ensure that they successfully complete mandatory Compliance and GCP training and pass related exams.
? Assist with audits and provide recommendations and assist in the implementation of Corrective Action Plans.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? Full knowledge of drug development process
? Full knowledge of applicable regulatory requirements, SOPs, and company’s Corporate Standards
? Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
? Strong knowledge of budget management and resourcing
? Strong working knowledge of medical terminology
? Strong knowledge of Microsoft Office and e-mail applications
? Effective communication, organizational, interpersonal, and leadership skills
? Strong negotiation skills
? Ability to independently coordinate and manage new processes
? Ability to lead and motivate teams
? Ability to handle management/personnel issues
? Ability to work independently and to effectively prioritize tasks
? Ability to work well within a matrix team environment
? Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
? Bachelor’s degree, preferred in Healthcare or other scientific discipline and 7 years of clinical trials experience including 3 years’ experience in a leadership capacity, a broad understanding of general management practices desirable (e.g. The Oz Principle, The 4 Disciplines of Execution); or equivalent combination of education, training and experience.
? Extensive use of keyboard requiring repetitive motion of fingers.
? Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
? Regular sitting for extended periods of time.
? May require occasional travel