TMF Document Specialist at IQVIA

Sofia, Sofia City Province, Bulgaria

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical ResearchIndustries

Requirements

Bachelor’s Degree in Records Management or related field
At least 4 years’ experience working in a Records Management technically related area
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

Responsibilities

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

Skills

Records Management

Trial Master Files

GCP

ICH

Regulatory Compliance

SOPs

Imaging

Scanning

Document Retention

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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