Summary: Under general direction, plans, coordinates and executes function specific clinical research programs for the clinical evaluation of products. Supervises assigned department staff.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
* Carries out managerial responsibilities in accordance with the organization?s policies, procedures, and state, federal and local laws.
* Oversees, directs, coordinates and prioritizes the daily activities of assigned staff.
* Establishes deadlines for conducting assigned tasks and assists in formulating an overall timetable for conducting clinical trials. Monitors progress of assigned tasks and instigates corrective action to met agreed deadlines.
* Interacts with contract research organizations (CRO). Investigators, consultants and vendors
* Estimate resource needs and assists in developing budget projections. Interviews potential candidates for open positions and makes hiring recommendations.
* Establishes performance standards for assigned activities and reviews output to ensure standards are consistently met. Conducts performance evaluations for direct reports and assists direct reports with performance evaluation process.
* Provides support, direction and coaching to assigned staff in areas of hiring, training, disciplinary action, problem resolution, planning and work assignment delegation.
* Assists with the development of and supports departmental operational procedures and systems.
* Manages, reviews and responds to audits of Phase II ? Phase IV studies and assists with the development of Corrective Action and Preventative Action Plans.
* Ensures compliance with all applicable local, state, and federal regulations and guidelines regarding the conduct of clinical trials (cGCP)
* Ensures compliance with all Company policies and procedures including safety rules and regulations.
* Performs related duties as assigned.
Required Knowledge and Skills:
* Pertinent Federal and State laws related to Pharmaceutical industry, Current FDA and Drug Enforcement Agency clinical requirements and cGMP?s.
* Current clinical research procedures and practices
* Federal regulations and guidance concerning the conduct of clinical research including Good Clinical Practice (GCP)
* Business, scientific and personal computer hardware and software applications.
* Business English usage, spelling, grammar and punctuation.
* Principles and practices of budget preparation and administration.
* Administration, supervision and training practices and methods.
* Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.
* Current Company policies, practices and procedures, including safety rules and regulations.
* Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
* Responding to inquiries from management, employees and regulatory agencies.
* Preparing, presenting and administering large, complex budgets and financial reports.
* Communicating clearly and concisely, both orally and in writing.
* Operating computers.
* Managing multiple projects, duties and assignments.
* Interpreting and applying Federal, state and local policies, procedures, laws and regulations.
* Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.
* Establishing and maintaining cooperative working relationships with others.
* Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution.
Minimum Qualifications: Bachelors degree in a scientific/technical or related field from an accredited college or university, and five (5) to seven (7) years pharmaceutical experience, including one (1) year in a supervisory or management capacity, or an equivalent combination of education and experience.