IQVIA is seeking an experienced Associate TMF Manager to join our dynamic team in Bengaluru, Karnataka. As the Associate TMF Manager, you will serve as a vital liaison between Records Management and user departments regarding Trial Master Files (TMFs), ensuring that all project-related work is conducted in accordance with standard operating procedures (SOPs), good clinical practices, and applicable regulatory requirements.
Key Responsibilities:
- Act as the primary contact for internal/external clients and ensure effective communication regarding Trial Master Files.
- Monitor project deadlines and commitments, ensuring that all goals are met on time.
- Provide records management expertise across multiple complex projects and teams.
- Coordinate the retrieval of records requested by users and prepare closed studies for transfer within agreed timelines.
- Assist management with resource projections, cost proposals, and implementation plans for records management projects.
- Train team members on records management tasks, policies, and procedures.
- Maintain accurate trackers and systems to control records and inventory.
- Oversee the transfer, recall, and disposition of records, ensuring proper disposal of obsolete records.
- Ensure compliance with SOPs and maintain records center security to protect record integrity.
Qualifications:
- Education: Bachelor’s Degree in healthcare or a scientific discipline, or equivalent combination of education, training, and experience.
- Experience: Minimum of 4 years in Records Management or a related technical field.
- In-depth knowledge of International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), and relevant local laws.
- Strong organizational, planning, and decision-making skills.
- Excellent oral and written communication abilities with a strong command of English.
- Proven capability to lead teams and establish effective relationships with internal and external clients.
- Ability to work under time pressure and manage multiple tasks and projects effectively.
About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. With a mission to accelerate the development and commercialization of innovative medical treatments, IQVIA creates intelligent connections aimed at improving patient outcomes and population health worldwide.
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