Remote TMF Quality Project Manager — LATAM

IQVIA; Bogotá; A distancia; COP 190.967.000 - 286.451.000; Jornada completa

Descripción de la vacante

IQVIA seeks a TMF Quality Project Manager or Records Management Analyst to oversee Trial Master File processes across LATAM. You will ensure SOP/GCP compliance, coordinate imaging, filing, and retention while guiding cross-functional teams.

This full-time remote role requires strong regulatory knowledge, excellent communication, and the ability to manage multiple records projects with tight timelines.

Formación

• Bachelor’s degree in Records Management or a related field, or equivalent combination of education, training, and experience.
• Minimum of four (4) years of experience in a technically related records management environment.
• Prior TMF oversight, review and/or reconciliation across clinical studies
• Knowledge of applicable research and regulatory requirements, including ICH, GCP, and local laws, regulations, and guidelines.
• Working knowledge of technology applications relevant to records management environments.
• Ability to identify and analyze problems, develop effective solutions, and make sound decisions.
• Demonstrated ability to manage multiple tasks and projects within defined timelines while balancing competing priorities.
• Strong attention to detail and ability to remain focused under pressure.
• Excellent organizational, planning, and decision-making skills.
• Strong written and verbal communication skills, including a solid command of English.
• Ability to establish and maintain effective working relationships with internal and external clients.
• Demonstrated ability to lead and guide others.

Responsabilidades

• Ensure project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of project-related and business records.
• Ensure all work is conducted in accordance with SOPs, policies, practices, Good Clinical Practice (GCP), 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 destinations within agreed timelines.
• Monitor filing accuracy and compliance with IQVIA or customer file plans and Standard Operating Procedures (SOPs).
• Conduct and manage imaging and scanning processes, and train staff on applicable imaging and scanning procedures.
• Maintain records center security to protect record integrity by ensuring compliance with SOPs.
• Interface with internal departments to support retrieval projects and ensure information needs are met.
• Train team members on records management tasks, policies, and procedures.
• Serve as the primary point of contact for internal and external clients.
• Coordinate the transfer, recall, and disposition of records to commercial records storage centers.
• Oversee the 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.

Conocimientos

Records management

Project coordination

Regulatory compliance

SOP/GCP knowledge

English proficiency

Team leadership

Educación

Bachelor’s degree in Records Management or related field

Descripción del empleo

IQVIA seeks a TMF Quality Project Manager or Records Management Analyst to oversee Trial Master File processes across LATAM. You will ensure SOP/GCP compliance, coordinate imaging, filing, and retention while guiding cross-functional teams.

This full-time remote role requires strong regulatory knowledge, excellent communication, and the ability to manage multiple records projects with tight timelines.