Description
Provide Trial Master File (TMF) - Quality checks related assistance to study teams. Apply Clinical Research Records Management expertise to provide project related assistance across multiple project(s), sites, and project teams.
Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics.
Essential Functions
- Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs)
- Establish and maintain effective internal and external client communications
- Design and administer records management systems and processes
- Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs
- Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects
- Perform assigned complex administrative tasks to support team members with project execution
- Assist in updating and maintaining complex data in systems within project timelines and per project plans
- May assist in the training and onboarding of new team members on departmental procedures
Qualifications
- Bachelor's Degree or High School Diploma or equivalent
- 0.5 - 2 years’ experience in an office environment. Equivalent combination of education, training and experience.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients, vendor, internal and external clients
- Strong organization and planning skills
- Attention to detail and accuracy in work
- Excellent oral and written communication skills including good command of English language
- Knowledge of word processing, spreadsheets, and database applications and accurate data entry skills
- Ability to remain focused with regards to details
- Ability to handle multiple tasks within defined timelines and significant direction