Assists in developing, implementing, and analyzing work within a specific or broad area of site start-up, such as site activation, regulatory / ethics submissions, site contracts, and / or post activation activities.
Ensures fulfillment of customer requirements and compliance with related regulations. Analyzes processes and develops strategies to increase efficiency.
Performs operational planning at the department or business unit level, including efficient allocation of resources within the department.
Functional Profit / Loss (P / L) responsibility for assigned projects, programs, and / or a portfolio of work. Supports business development selling efforts and may directly represent the Company in functional service opportunities.
May oversees people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.
Ability to mentor and coach managers and supports team managers on all administrative or departmental activities.
Facilitates processes, resourcing, and communications within a department, across departments, or within the country assigned.
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.
Serves as a departmental point of escalation for internal and external customers.
May be responsible & accountable for the effective operations and SSU project deliverables across all regions, within the assigned programs / projects.
May develops and maintains strategic relationships with customers. Collaborates with business leads for business development, alliance management, contracts and proposals development, project management, clinical management, operational personnel, and executive management to achieve project goals.
Ensures that individual project targets are met, clients are satisfied, services are provided with the highest quality standards and policies and procedures are followed.
May supports management with site start-up 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 reporting of department and team metrics / cycle times and strategies to improve metrics / cycle times Guarantees SSU delivery of assigned projects and / or initiatives.
Involved in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams.
Interacts with internal or external Legal Departments and assists with the accurate creation and implementation of contract management workflows or with the contract management group.
Identifies and reports on areas of process and contract risk.
Oversees the implementation of 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, metrics and reports based on input from functional teams.
Provides input and requirements for long-range IT plans. Implements Company and / or customer-required project management systems and processes.
Leads larger 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.
Responsible for creating a predictable project experience for both employees and clients alike.
Contributes to and may lead change initiatives across the SSU and Regulatory department.
Develops and implements strategies and tools for tracking 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 (please indicate if preferred’)
Experience in managing teams of clinical research employees
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
Extensive Clinical Trial experience
Sales experience preferred.
Strong knowledge of clinical research management processes.
Understanding of the needs of countries and the ability to work across geographic regions.
Strong CRO operational experience with a track record in project management working in an international or global capacity.
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.