Manager-Clinical Trial Post Award

Shared Services: Clinical Trial Center- (Full-Time, Day Shift) -

Job Summary: The Manager-Clinical Trial Post Award reports to the Executive Director and serves as an expert with extensive knowledge and experiences in clinical trial management, as well as understanding of rules and regulations and federal, state, and local laws related to research. Trains junior staff and performs on pre-trial services. Provides site training and resources for trial management to clinical departments. Assists Director and Executive Director in resolving issues that prevent trial compliance and efficiency. Collaborates extensively with pre-trial team, clinical trial site personnel (e.g., PI and study coordinator) and ancillary service providers to ensure that standard procedures are followed, and trials are making good progress. Performs other duties as needed.

Education and Experience: Bachelor's degree in health administration, public policy, or a health-related field required. Master's degree preferred. Minimum five years of related clinical trial experience required. Minimum three years of experience in management role required. Must have documented successful research administration experience focused on managing a clinical trials function.

Knowledge and Skills: Knowledge of FDA regulations, GCP, ICH guidelines and NCD required. Ability to critically review existing and create policies and procedures pertaining to clinical trials. Demonstrated ability to develop and maintain education portfolio for clinical trial activity. Essential Technical/Motor Skills: Able to read; write and speak with professional quality; use computer and software programs necessary to the position, e.g., Word, Excel, Power Point, Access; operate/troubleshoot basic office equipment required for the position. Essential Interpersonal Skills: Able to relate and communicate positively, effectively, and professionally with others; provide leadership; be assertive and consistent in enforcing policies; work calmly and respond courteously when under pressure; lead, supervise, teach, and collaborate; accept direction. Essential Mental Abilities: Able to communicate effectively in English in person, in writing, and on the telephone; think critically; work independently; perform basic math and statistical functions; manage multiple assignments; compose written material; work well under pressure; problem solve; organize and prioritize workload; recall information with accuracy; pay close attention to detail. Essential Sensory Abilities: Able to distinguish colors as necessary; hear sufficiently for general conversation in person and on the telephone, and identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, and written documents necessary to the position.

Licensures and Certifications: None.