Associate Director, Research Site Ops
This position supports Frenova Renal Research division and the (4) sites located in Utah, Colorado, Nevada & Idaho.
PURPOSE AND SCOPE: Monitors and tracks the progress of clinical study activity at research sites. Provides support with regulatory agency and sponsor inspections/audits as needed. Under the supervision of the Director, Site Operations, the Associate Director, Research Site Operations will provide administrative support the Director, other Frenova leaders, and Frenova Renal Research staff across multiple sites. Performs duties governed by Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines. Complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• Represents company vision to employees and external customers
• Maintains strictest confidentiality
• Responsible for the routine cross-functional operations of multiple sites across the Site Management Organizations (SMO)
• Supports the administration of business processes and services to ensure the operations effective achievement of goals within the SMO
• Manages Site Senior Managers, Managers and supports all SMO site support staff
• Assists in controlling the broad activities of the business unit(s) through the interpretation, application and implementation of company-wide policies and processes appropriate to the functional area(s)
• Assists with communications, initiates, and directs contract completion while integrating input from Legal, Compliance and other involved entities
• Assists operational efforts for the Site Management Organization (SMO) as new sites are onboarded into organization
• Assists operational efforts through subordinates to complete the administration of business processes and services to ensure the operations effective achievement of goals within the assigned business unit(s)
• Provides leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters as needed
• Assists with problem solving among the department managers and other site leadership as they arise
• Works with the Compliance, Legal and Audit departments as necessary to develop or refine policies and procedures pertaining to Frenova’s business
• Presents and participates at meetings with internal and external representatives as needed, often leading a cooperative effort among members of a project team
• Assists in developing operational policies in collaboration with the Director as needed, and establishes procedures that positively affect provided services
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements at multiple locations, mitigating foreseeable risks by continual oversite and audit
• Evaluates site implementation of improvement programs ensuring clinical trial enrollment goals are met according to project timelines across multiple sites
• Supports in implementation new site start up procedures, meetings, and staff training
• Performs other related duties as assigned.
• Assists leadership in ensuring budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• This job operates in an office or remote setting. While performing the duties of this job, the employee is regularly required to talk and hear. This role routinely and frequently uses a desk and standard office equipment such as computers, phones, and photocopiers with repetitive motion.
• Physical effort required. Employee must be able to lift and carry up to 30 pounds.
• Travel is required, between 35-40%.
• Manages subordinate supervisors and/or predominately exempt staff – experienced specialist/professional employees who exercise significant latitude and independence.
EDUCATION AND REQUIRED CREDENTIALS:
• Bachelor’s Degree; Advanced Degree preferred or an equivalent combination of education and experience
• Clinical research certification required
EXPERIENCE AND SKILLS:
• 8+ years related experience or an equivalent combination of education and experience.
• 5+ years’ experience in a senior managerial role
• Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship
• Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers
• Demonstrated experience managing one or more departments
• Strong management skills with the ability to lead cohesive and productive teams
• Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact
• Excellent oral and written communication skills
• Dialysis experience preferred
• A track record of success in a fast-paced team environment working under very tight deadlines and ability to meet or exceed deadlines
• Strong project management skills
• Proficient in the use of electronic systems and the Microsoft Office suite of products
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.