Quality Project Manager

This is a fully remote position, open to applicants in Argentina, +2 more countries.

📋 Description

• Act as the intermediary between Records Management and user departments concerning Trial Master Files.

• Utilize expertise in clinical research records management to offer project-related support across various projects, sites, and teams.

• Ensure adherence to SOPs, policies, Good Clinical Practice (GCP), relevant regulatory requirements, and quality and timeline benchmarks.

• Guarantee that project timelines are adhered to and facilitate the transfer, imaging, scanning, retention, and disposal of records.

• Coordinate the retrieval of requested records and prepare closed studies for their final transfer destinations.

• Oversee filing accuracy and compliance with IQVIA or customer file plans and SOPs.

• Manage imaging and scanning processes while training staff on relevant procedures.

• Uphold records center security and safeguard record integrity through compliance with SOPs.

• Collaborate with internal departments to support retrieval projects and satisfy information needs.

• Train team members on tasks, policies, and procedures related to records management.

• Act as the primary point of contact for both internal and external clients.

• Oversee the transfer, recall, and disposal of records to commercial records storage facilities.

• Manage the disposal of outdated records and the upkeep of records storage space, supplies, and equipment.

• Assist management in achieving strategic goals, planning, cost proposals, and resource forecasting for records management projects.

• May serve as the team leader for records management initiatives.

⛳️ Requirements

• Bachelor’s degree in Records Management or a related discipline, or equivalent combination of education, training, and experience.

• A minimum of four (4) years of experience in a technically related records management setting.

• Previous experience overseeing, reviewing, or reconciling Trial Master Files (TMF) across clinical studies.

• Comprehensive knowledge of applicable research and regulatory standards, including International Council for Harmonization (ICH), Good Clinical Practice (GCP), and pertinent local laws, regulations, and guidelines.

• Proficient understanding of technological applications relevant to records management environments.

• Capability to identify and assess problems, create effective solutions, and make informed decisions.

• Proven ability to handle multiple tasks and projects within specified timelines while managing competing priorities.

• Exceptional attention to detail and ability to maintain focus under pressure.

• Outstanding organizational, planning, and decision-making capabilities.

• Strong verbal and written communication skills, with a solid command of the English language.

• Ability to establish and maintain effective working relationships with both internal and external clients.

• Demonstrated capability to lead and mentor others.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Generous paid time off (PTO) policy and flexible work schedules.

• Opportunities for professional development and career advancement.

• Supportive and inclusive work environment.