Remote Senior Project Management & Records Analyst

Bgp Inc Sucursal Nueva Granada; Girardot; A distancia; COP 280.260.000 - 404.820.000; Jornada completa

Descripción de la vacante

IQVIA seeks a Senior Quality Project Manager or Records Management Analyst to oversee TMF and records management across global trials from a fully remote LATAM base. This role requires collaboration with Clinical Project Managers and cross-functional study teams to ensure compliance with SOPs, ICH-GCP, and regulatory standards.

The successful candidate will manage timelines, budgets, and training, mentor junior PMAs, and coordinate data transfer to central repositories while upholding data

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 experience with Trial Master File (TMF) oversight, review and/or reconciliation across clinical studies
• Strong knowledge of applicable research and regulatory requirements, including ICH, GCP, and relevant local laws, regulations, and guidelines.
• Working knowledge of technology applications relevant to records management environments.

Responsabilidades

• Serve as liaison between Records Management and user departments for TMF-related projects.
• Ensure SOPs, GCP, and regulatory requirements are followed with quality and timeliness.
• Coordinate retrieval of records and prepare closed studies for transfer within timelines.
• Monitor filing accuracy and compliance with IQVIA or customer file plans and SOPs.
• Conduct and manage imaging and scanning processes and train staff on procedures.
• Maintain records center security to protect record integrity.

Conocimientos

Project management

Records management

TMF oversight

GCP/ICH knowledge

English proficiency

Educación

Bachelor's degree in Records Management

Herramientas

eTMF

CTMS

Descripción del empleo

IQVIA seeks a Senior Quality Project Manager or Records Management Analyst to oversee TMF and records management across global trials from a fully remote LATAM base. This role requires collaboration with Clinical Project Managers and cross-functional study teams to ensure compliance with SOPs, ICH-GCP, and regulatory standards.

The successful candidate will manage timelines, budgets, and training, mentor junior PMAs, and coordinate data transfer to central repositories while upholding data