Remote Software Project Lead - Agile, Multistream Delivery

Bluelightconsulting; Quilmes; Remote; ARS 91,242,000 - 136,863,000; Full time

Benefits offered by this job

Flexible work schedule

Home-based position

Ongoing learning and development

Job summary

Indero is seeking a TMF Quality Project Manager or Records Management Analyst to serve as the liaison between Records Management and user departments across LATAM. The role ensures compliance with SOPs, GCP, and regulatory requirements while meeting quality and timeline metrics in a fully home-based setup.

The ideal candidate will supervise TMF activities, coordinate imaging and file transfers, and lead records management projects with strong communication and organizational skills.

Qualifications

• Bachelor's degree in Records Management or related field or equivalent experience.
• Minimum of four years in a technically related records management environment.
• Experience with TMF oversight, review, and reconciliation across clinical studies.
• Knowledge of GCP/ICH, FDA and local regulations.

Responsibilities

• Ensure project timelines are met and manage transfer, imaging, scanning, retention, and disposition of records.
• Coordinate retrieval of records and prepare closed studies for transfer.
• Monitor filing accuracy and compliance with file plans and SOPs.
• Lead imaging/scanning processes and train staff on procedures.
• Maintain security of records storage and ensure SOP compliance.
• Interface with internal departments to support retrieval projects and information needs.
• Train team members on records management tasks and policies.
• Act as primary contact for internal and external clients.
• Coordinate transfer and disposition of records to storage centers.
• Oversee disposal of obsolete records and optimize storage space.

Skills

Communication skills

English proficiency

Problem solving

Project coordination

Team leadership

Education

Bachelor's degree in Records Management or related field

B.Sc. in clinical research related field

Tools

Microsoft Office

Job description

Job Title and Summary

TMF Quality Project Manager or Records Management Analyst (Full home-based LATAM)

Location

• Buenos Aires, Argentina
• São Paulo, Brazil
• Bogotá, Colombia

Employment Type

Full time, Remote

Company

Indero

Company Culture

At Indero, we are a contract research organization specializing in dermatology and rheumatology. Founded in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. We are committed to providing equitable treatment and equal opportunity to all individuals, and we provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Role Overview

The TMF Quality Project Manager or Records Management Analyst is responsible for serving as the liaison between Records Management and user departments regarding Trial Master Files. The role applies clinical research records management expertise to provide project‑related assistance across multiple projects, sites, and project teams, ensuring all work is conducted in accordance with SOPs, policies, practices, Good Clinical Practice (GCP), and applicable regulatory requirements while meeting quality and timeline metrics.

Key Responsibilities

• Ensure project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of project‑related and business records.
• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destinations.
• Monitor filing accuracy and compliance with IQVIA or customer file plans and SOPs.
• Conduct and manage imaging and scanning processes, and train staff on applicable 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.

Qualifications

• 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 working 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.
• 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 the English language.
• Ability to establish and maintain effective working relationships with internal and external clients.
• Demonstrated ability to lead and guide others.

Experience

• At least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology, and/or CRO industry.
• At least 2 years experience coordinating activities related to clinical trial management.
• At least 4 years of experience working in a technically related records management environment.
• Experience managing dermatology and/or rheumatology trials and leading concurrent multi‑centered clinical trials with budgets in excess of $3M USD.

Education

• B.Sc. in a related field of study to clinical research.
• Minimum bachelor’s degree or its equivalent.

Skills and Knowledge

• Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations.
• Excellent knowledge of Microsoft Office suite.
• Excellent oral and written skills in English; French is an asset.
• Excellent communication skills.
• Ability to work in a team environment and establish good relationships with colleagues and sponsors.
• Good problem‑solving abilities.
• Good organizational skills.
• Strong ability to carry out different projects and work under pressure while meeting timelines.
• Experience managing small to medium projects using a disciplined approach to project management.
• Core Project Management competencies: demonstrate ability to establish and deliver resource‑based project plans, manage risk and control measures, analyze discrepancies, provide approval, etc.

Benefits and Perks

• Flexible work schedule / work schedule.
• Home‑based position.
• Ongoing learning and development.

EEO Statement

EEO Minorities/Females/Protected Veterans/Disabled.

Eligibility and Work Authorization

Indero only accepts applicants who can legally work in Argentina.