Provides 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) are followed and the client’s study is progressing according to internal and Customer quality standards, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, fulfilling all federal and local regulations. Provides strategic and operational level planning. Drive ‘positive change’ throughout the company through effective participation in continuous process improvement program.
1. Participates in both short and long-term planning for all aspects of the Company’s operations and growth. Contributes operational input to other departments as appropriate, including developing and distributing appropriate reports to executive management.
2. Manages 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. Reviews performance of the Company’s activities and makes recommendations for improvement in quality/efficiency. Periodically, participates in conducting annual site evaluations.
3. Reviews and provides input on study proposals, while participating in the sales and marketing function as it relates to the Company’s clinical operations activities. Participates as a primary source of operations information in the budgeting process for clinical studies and the department.
4. Liaison and facilitator between the Company’s operation’s departments and clinical business units for project related tasks and/or issues. Plans and negotiates resources with line management of functional areas. Serves as a Project Advisor on project teams by providing input regarding the operational and project management aspects of the projects.
5. May develop and refine project management processes within the Company, using established process modeling techniques. Leads 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. 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. Implements enterprise wide project management systems and tools. Evaluates project progress, while producing and distributing resource status reports as well as functional area plans, to appropriate members of executive and senior management.
6. Ensures thorough clinical study feasibility and appropriate distribution of studies to consortium sites. Develops, collects, and analyzes project metrics, while holding project reviews with operational staff focusing on budget, schedule and risk analysis.
7. Develops the 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. Plans for the efficient allocation of resources within operations.
8. Ensures compliance with GCP sponsor contracts as well as all Food and Drug Administration (FDA) and ICH requirements. Develops and implements policies, procedures and (SOPs) for clinical operations activities, as well as applicable training programs for staff and network sites. Interacts with senior management of pharmaceutical and biotechnology sponsors on operational issues.
9. Within the department, approves 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. Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods.
Performs other work-related duties as assigned. Moderate travel may be required (up to 50%).
Interview candidates for positions in project teams. Represents the Company at professional meetings or seminars. Establishes and maintains training materials for project managers. Provide input and requirements for long range IT/enterprise plans.
BA/BS degree or equivalent combination of education and experience; and extensive management experience preferably in a worldwide clinical research, pharmaceutical, or biotechnology company. MBA or other relevant advanced degree preferred. Comprehensive management skills and experience, including but not limited to short and long-term planning, evaluation, directing and motivating staff, marketing and financial management. Thorough knowledge of FDA regulations, drug development, and clinical project management procedures is necessary.
Additional 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 is essential. Must have a record of engaging diverse interests for the common good; adept at marketing and able to communicate and work with a diverse group of individuals to accomplish common goals. Membership and/or affiliations with applicable professional organizations related to the Company’s business are highly preferred. Highly effective strategic planning, communication, written, presentation and analytical skills. Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail. Experience working in a matrix team environment is preferred.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Primary Location North America - US Home-Based
Job Clinical Monitoring
Travel Yes, 25 % of the Time
Employee Status Regular