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The Project Manager is responsible for overseeing clinical trial study activities from start-up through closeout, including data management and quality control. They also provide technical support and training for the EXCELSIOR cloud application to sponsors, reading centers, and clinical sites.
SUMMARY:
Accomplishes the day-to-day operations of project management and accurately and competently administers activities regarding assigned studies. Responsible for all study activities; study start up through closeout. Primary functions include assisting project management of clinical trial data in the EXCELSIOR™ cloud application environment; perform data upload, quality control functions; maintenance of controlled documents including Master Project Files; and provide support functions for clinical sites, reading centers and clients using EXCELSIOR™ according to MERIT and/or study specific procedures and Good Clinical Practices (GCP).
ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)
Administrative Duties:
Study-Related Duties:
Software-related Duties:
Other:
The following are the essential functions of the position but are not all-inclusive.
Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
Demonstrates a commitment to maintain safe, clean and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.
QUALIFICATION REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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.
Education and Experience:
Minimum of a Bachelor’s degree in a health related, biological science, computer science, data entry, customer service or business management is preferred, or a equivalent combination of education, training, and work experience.
A minimum of two (2) years of clinical trial or project management experience in a related field.
Other Skills and Abilities:
Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess Company needs and work independently. Computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software. Must be able to project a professional attitude and image appropriate for the work environment.
Ability to participate and contribute in a team environment as a team member. Oral and written communication is clear, concise, and effective.
Licenses or Certifications Required:
None.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
While performing the duties of this job, the employee is regularly required to use hands; to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The noise level in the work environment is usually quiet to moderate.
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