[Hiring] Project Manager I @MERIT CRO, Inc.

Role Description

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
• Performing data upload and quality control functions
• Maintenance of controlled documents including Master Project Files
• Providing support functions for clinical sites, reading centers, and clients using EXCELSIOR™ according to MERIT and/or study specific procedures and Good Clinical Practices (GCP)

Qualifications

• Minimum of a Bachelor’s degree in a health related, biological science, computer science, data entry, customer service, or business management is preferred, or an 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
• Strong interpersonal and organizational skills
• Excellent attention to detail
• Ability to follow direction, assess company needs, and work independently
• Proficiency in Microsoft Office software and ability to learn company specific software
• Ability to participate and contribute in a team environment
• Clear, concise, and effective oral and written communication

Requirements

• 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
• Perform and oversee all study activities from start-up through close out and data lock
• Organize and prioritize work assignments to complete assignments and tasks on time
• 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
• Initiate Master Project File and maintain project documents
• Attend project meetings internally and with sponsor (via teleconference or face-to-face) throughout the project
• Generate and email eligibility reports and notifications
• Independently process clinical data from start up through database lock prioritizing work to meet project timelines
• Understand the EXCELSIOR™ product, protocol, and conduct of clinical trials
• Provide guidance and training to sponsors, CROs, and clinical sites on the use of EXCELSIOR™
• Ensure accurate and efficient set up of EXCELSIOR™ for assigned project(s)
• Complete the initial configuration of studies within EXCELSIOR™
• Manage and review site surveys; update EXCELSIOR™ for site registration
• Comply fully with company policies and Standard Operating Procedures (SOPs)

Benefits

• 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 a safe, clean, and orderly work area
• Promotes and follows safety regulations and actively contributes to work safety

Physical Requirements

• Regularly required to use hands; to touch, finger, grasp, handle or feel, with repetitive motions, and talk or hear
• Frequently required to stand, walk, and sit
• Occasionally required to reach with hands and arms, stoop, crouch, kneel, and climb
• Must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
• Specific vision abilities required include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus

Work Environment

• The noise level in the work environment is usually quiet to moderate