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Provide Trial Master File (TMF) - Quality checks related assistance to study 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.
Ensure that project timelines are met and facilitate the orderly imaging, transfer, retention, and disposition of various project-related and business records. Administer records management systems.
Essential Functions
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
Coordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelines
Conduct and manage scanning processes and train staff on scanning processes
Interface with departments to support retrieval projects and ensure information needs are met
Serve as primary contact for internal/external clients
Monitor and review filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs) where applicable
Maintain records center security to protect record integrity by ensuring compliance to SOPs
May coordinate transfer, recall, and disposition of records to commercial records storage centers
Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment
Train team members on records management tasks, policies, and procedures
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
May function as team leader for records management projects
Qualifications
Bachelor's degree or equivalent
3-4 years' experience working in relevant clinical research environment. Equivalent combination of education, training and experience.
Good knowledge of applicable clinical research regulatory requirements, i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines;
Knowledge of technology applications relevant to records center environments.
General knowledge of computer technology and software programs, and accurate data entry skills.
Attention to detail and accuracy in work.
Ability to achieve productivity despite time pressure constraints.
Good problem-solving skills.
Strong organizational, planning, and decision-making skills.
Good time management and prioritization skills.
Extensive knowledge of records management laws and regulations.
Excellent oral and written communication skills including good command of English language.
Ability to manage and lead others.
Ability to establish and maintain effective working relationships with internal and external clients.
Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
Position is required to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms.
Position is required to stoop, kneel and may need to utilize a ladder for paper files on high-density file systems.
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