Assists senior management in managing work and teams within a specific or broad area of site start-up, such as site activation, regulatory / ethics submissions, site contracts, and / or life cycle maintenance activities.
Ensures fulfillment of customer requirements and compliance with related regulations. Analyzes processes to increase efficiency.
Performs operational level planning, including efficient allocation of resources within the department. Participates in business development presentations as a subject matter expert in Site Start-Up & Regulatory functions within the Company.
Conducts people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.
Provides guidance on administrative policies and procedures, technical problems, priorities, and methods.
Acts as liaison and facilitator between customer leaders and senior management for related tasks and / or issues. Plans and negotiates resources with line management of functional areas.
Supports management with site start-up or maintenance and financial management tasks of projects, as well as strategy development for process improvement.
Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis.
Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings.
Develops and implements training programs for appropriate departmental teams.
Interacts with the executive management and Legal Department and assists with the accurate creation and implementation of site contracts, site start-up, maintenance and regulatory management workflows.
Identifies and reports on areas of process and risk.
Implements customer-required and / or enterprise-wide project management systems and tools. Participates in the development, implementation, and maintenance of enterprise project management systems, acting as a systems manager;
may supervise a systems administrator.
Develops requirements for modifications to existing systems and reports based on input from functional teams. Provides input and requirements for long-range IT plans.
Implements Company and customer-required project management systems and processes.
Leads teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes.
Develops and implements strategies and tools for tracking contract management team metrics / cycle times. Oversees all quality control efforts of individual departmental teams.
Represents the Company at professional meetings or seminars.
Establishes and maintains training materials for assigned area.
QUALIFICATION & REQUIREMENTS
Experience in a clinical research organization and related contract management or site start-up experience.
Background in development / management of information systems and process engineering preferred.
Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
Strong presentation, documentation, and interpersonal skills.
Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
Demonstrate line management abilities.
Strong leadership skills; ability to teach / mentor team members.
Ability to coach employees to reach performance objectives.
Ability to recognize and take appropriate action when employee performance is not acceptable.