TMF Archivist, Sponsor-Dedicated (m/w/d), Hybrid Germany in Frankfurt, Germany

Job Overview:

The TMF Archivist will be responsible for both Global and Local TMF activities (archiving) and will 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. May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources.

This hybrid position requires presence in Biberach either twice a week or one full week every three weeks.

Essential Functions

• Ensure that project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of various project-related and business records

• Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics

• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within agreed timelines

• Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs);

• Conduct and manage imaging/scanning processes and train staff on imaging/scanning processes

• Maintain records center security to protect record integrity by ensuring compliance to SOPs

• Interface with departments to support retrieval projects and ensure information needs are met

• Train team members on records management tasks, policies, and procedures

• Serve as primary contact for internal and external clients

• 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

• Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects

• May function as team leader for records management projects.

Qualifications

• Bachelor’s Degree Records management or related field Req

• 3/4 years of TMF experience with a focus on Good Documentation Practice & archiving aspects. Equivalent combination of education, training and experience.

• Strong knowledge of applicable research and 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 management environments.

• Ability to perceive and analyze problems, develop solutions, and make sound decisions.

• Ability to handle multiple tasks and projects within defined timelines and balance competing priorities.

• Ability to remain focused with regards to details under pressure.

• Strong organizational, planning, and decision making skills.

• Excellent oral and written communication skills, including good command of English language.

• Ability to establish and maintain effective working relationships with internal and external clients.

• Ability to lead others.

• Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.

• Regular sitting for extended periods of time.

• This hybrid position requires presence in Biberach either twice a week or one full week every three weeks.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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