You will provide senior level direction and management associated with the Company’s business operations, ensuring the Company’s TrustedProcess™ methodology, project management practices, and Standard Operating Procedures (SOPs) to ensure internal and Customer quality standards, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and all federal and local regulations are fulfilled. You will provide strategic and operational level planning, and you will drive ‘positive change’ throughout the company through effective participation in our continuous process improvement program.
1. You will participate in both short and long-term planning for all aspects of the Company’s operations and growth. You will contribute operational input to other departments as appropriate, including developing and distributing appropriate reports to executive management.
2. You will manage the forecasting, planning and logistics for clinical operations activities, including the direction and scheduling of clinical operations resource allocations, ensuring performance and quality standards are met. You will review performance of the Company’s activities and make recommendations for improvement in quality/efficiency. Periodically, participates in conducting annual site evaluations.
3. You will review and provides input on study proposals, while participating in the sales and marketing function as it relates to the Company’s clinical operations activities. You will participate as a primary source of operations information in the budgeting process for clinical studies and the department.
4. You will serve as Liaison and facilitator between the Company’s operation’s departments and clinical business units for project related tasks and/or issues. You will plan and negotiate resources with line management of functional areas. You will serves as a Project Advisor on project teams by providing input regarding the operational and project management aspects of the projects.
5. You may develop and refine project management processes within the Company, using established process modeling techniques. You will lead teams of subject matter experts to develop and review SOPs and WIs related to any area concerning project management to support new or existing project management processes. You may work with the Project Manager on the study start up and financial management tasks of a project to ensure success of the overall project. You will implement enterprise wide project management systems and tools. You will evaluate project progress, while producing and distributing resource status reports as well as functional area plans, to appropriate members of executive and senior management.
6. You will ensure thorough clinical study feasibility and appropriate distribution of studies to consortium sites. You will develop, collects, and analyzes project metrics, while holding project reviews with operational staff focusing on budget, schedule and risk analysis.
7. You will manage the development of clinical research capabilities within the Company’s member sites as performed through leadership and management of field operations activities as required. Implements global project management systems and processes to increase efficiency. You will plan for the efficient allocation of resources within operations.
8. You will ensure compliance with GCP sponsor contracts as well as all Food and Drug Administration (FDA) and ICH requirements. You will develop and implement policies, procedures and SOPs for clinical operations activities, as well and biotechnology sponsors on operational issues.
9. Within the department, you will approve courses of action on all management / human resources’ matters, including salary administration; employment hires, transfers, terminations; performance appraisals and professional development; job description preparation, and employee counseling. You will work with and advise staff on administrative policies and procedures, technical problems, priorities and methods.
You will perform other work-related duties as assigned. Moderate travel may be required (up to 50%).
Interview candidates for positions in project teams. You will represent the Company at professional meetings or seminars. You will establish and maintain training materials for project managers. You will provide input and requirements for long range IT/enterprise plans.
You will have a Bachelor’s degree in the life sciences or equivalent combination of education and work experience. An MBA or other relevant advanced degree preferred. You will have extensive senior management experience, preferably in a worldwide clinical research, pharmaceutical, or biotechnology company. You will possess comprehensive management skills and experience, including but not limited to short and long-term planning, evaluation, directing and motivating staff, marketing and financial management. You will have a thorough knowledge of FDA regulations, drug development, and clinical project management procedures. Additionally, your experience developing and setting corporate plans and objectives that support the organization’s worldwide drug development processes, while making critical decisions related to changing the direction of the business will be essential. You must have a record of engaging diverse interests for the common good; you’ll be adept at marketing and able to communicate and work with a diverse group of individuals to accomplish common goals. Your membership and/or affiliations with applicable professional organizations related to the Company’s business are highly preferred. You will have highly effective strategic planning, communication, written, presentation and analytical skills. You’ll have an advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail. Your experience working in a matrix team environment is preferred.
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Primary Location North America - US Home-Based
Job Clinical Monitoring
Travel Yes, 50 % of the Time
Employee Status Regular