In conjunction with internal management, the Study Manager (SM)
organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development Plan. The SM is responsible for ensuring clinical study quality/consistency of performance and in conjunction within Clinical Operations and all other Team members is responsible for overall timeline adherence and performance against plan of the clinical study. A critical component of the position is the peer management and/or support of and coordination with contract research organization personnel (CROs), consultants, contractors, and other colleagues to ensure adequate resource volume and quality is maintained on the studies for which the SM is responsible.
Some travel is required.
· AA or 4-year degree preferably in the biological sciences. Requires a good understanding of medical terminology.
· 3 years clinical trial management experience in the pharmaceutical industry preferably with 5+ in clinical operations.
Other Skills and Abilities:
· Attention to details.
· Solution oriented and exceptional collaboration skills.
· A team player and able to work in a dynamic environment with attention to high quality reslts.
· Understand the needs of others.
· Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.
· Well organized.
· Excellent communication skills both verbal and written.
· Professional in appearance and manner.
· Ability to multi-task effectively and efficiently on a variety of projects.
· Good team player with positive "can do" attitude.
· Ability to focus on projects and work with minimal supervision.
· Good proofreading skills.
· Takes initiative and utilizes good judgment.
· Ability to effectively present information and respond to questions internally and externally.
· Open and clear communicator.
· Ability to work with mathematic concepts such as probabilities and statistics.
· Ability to apply concepts such as proportions, fractions, percentages, to practical situations.
· Ability to collect information; define problems, establish facts, draw conclusions and propose feasible actions.
· Outstanding computer skills in Word, Excel, PowerPoint, and MS Project
· While performing the duties of this job, the employee is frequently required to sit, talk and hear
· The employee is occasionally required to walk.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The incumbent in this position may be required to perform other duties, as assigned.