Project Manager I - REMOTE ROLE

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:

• Manage office tasks including organization and coordination of controlled documents
• Assist in development of project and regulatory documents; includes proofreading of documents
• Respond to quality review audits and clearly document responses to facilitate resolutions
• Assist with the development/implementation of training programs
• Monitor own work to ensure quality and completeness
• Ability to work with limited supervision

Study-Related Duties:

• Perform and oversee all study activities from start-up through close out and data lock 
• Organizes and prioritize work assignments to complete assignments and tasks on time, with quality and has the ability to anticipate problem areas in advance. Apply creative approaches and ideas to solve problems maximizing effective use of appropriate resources.
• Prepare study start up materials, organize and conduct internal study start up meeting, and follow up on action items
• Establish and maintain routine communication among the Project Management Division, Sponsor, site staff, and other designated parties.
• Assist with the development of new study specific processes and procedures
• Initiation of Master Project File and maintenance of project documents
• Establish study files and create and distribute study documents
• Attend project meetings internally and with sponsor (via teleconference or face-to-face) throughout the project
• Maintain established study specific systems and procedures for regular status updates, site information lists, revisions of plans or study documents and routine correspondence.
• Generate and email eligibility reports and notifications 
• Generate and provide study reports and updates
• Independently process clinical data from start up through database lock prioritizing work to meet project timelines
• Responsible for assisting in all aspects of study conduct, initiation through closeout

Software-related Duties:

• Understand the EXCELSIOR™ product, protocol and conduct of   clinical trials in sufficient detail to be able to adequately discuss tasks with study team members
• Provide guidance and training to sponsors, CROs and clinical sites on the use of EXCELSIOR™, including software functionality and technical support
• Ensure accurate and efficient set up of EXCELSIOR™ for assigned project(s) through reviews, user acceptance testing, and study specific imaging charter review and development
• Complete the initial configuration of studies within EXCELSIOR™ 
• Assist with the review of EXCELSIOR™ study specific configuration
• Develop and perform project specific user acceptance testing, involving reading center personnel as applicable
• Ensure the internal team is appropriately trained in the use of EXCELSIOR™, and if required, provide additional training support and development
• Manage and review site surveys; update EXCELSIOR™ for site registration
• Clinical site technician and equipment certification
• Image check-in and quality control
• Issue and review data query responses to ensure completeness and accuracy of response relative to other data
• Review, categorize, and respond to customer support and complaint tickets in the helpdesk application
• Follow up with sites, sponsors, and reading center personnel on EXCELSIOR access; review inactive user reports

Other:

• Comply fully with company policies and Standard Operating Procedures (SOPs)
• Other responsibilities may be assigned as required

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.