BASIC SUMMARY: Manage the department, and all functions related to the generation of protocols through the final protocol and the study report. In addition, manage the raw data library and receptionist.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manage activities of assigned group(s) to ensure effective performance of function
- Ensure timely preparation of protocols, in-life coordination in support and on behalf of study directors, methods development, table development and production of final report.
- Assure that areas of responsibility are in compliance with domestic and foreign Good Laboratory Practices and other applicable regulations.
- Manage and resolve strategic study management issues within and external to the function.
- Oversee preparation of responses to both internal and external quality assurance audits.
- Interview and select qualified exempt- and non-exempt level departmental personnel. Recommend, review and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork.
- Identify training and development needs of direct reports. Develop and oversee the implementation of departmental training programs, including orientation; monitor training programs to ensure ongoing effectiveness.
- Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports.
- Authorize overtime as needed. Review and approve time cards. Review and approve vacation/time off requests and coordinate vacation/time off schedules.
- Develop short- and long-range operating objectives, organizational structure, and staffing requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel.
- Assist in the development and recommendation of departmental budget. Authorize expenditures in accordance with budget. Approve budget and expenses of subordinates.
- Determine and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
- Direct the development and communication of departmental systems, SOPs, policies and procedures. Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.
- Perform all other related duties as assigned.
- Education: Bachelor’s degree (B.A./B.S.) or equivalent in life sciences or related discipline.
- Experience: 6 to 8 years related experience, preferably within a GLP environment.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Other: Excellent verbal and written communication skills as well as organizational skills. Demonstrated independent analytical and problem-solving abilities. Knowledge of GLP regulatory requirements. Ability to work effectively as a member of a team. Ability to work in a dynamic, detailed driven environment. Ability to handle multiple projects, prioritize work and meet deadlines. Computer proficiency in MS Word, Excel, Outlook and SharePoint. Proficiency in computer programs (e.g., Provantis) and procedures used to accomplish data reduction. Proficiency in regulatory submission software (e.g., ISI Publisher, ISI Toolbox) and experience using statistical analysis software (e.g., Nevis) is desired.
Req ID #: 43308