TMF Document Specialist (Clinical Research)

Location: Dalian, Liaoning, China; may require shift work and prolonged sitting, standing, walking, lifting up to 40 pounds/18 kg, and use of ladders for high-density paper files.

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Perform complex administrative tasks and maintain project data in records-management systems according to project plans and timelines.
• Coordinate record retrieval, scanning, transfers, recalls, disposition, and preparation of closed studies for final destinations.
• Monitor filing accuracy, compliance with hirify.global or customer file plans, SOPs, clinical research requirements, and records-management regulations.
• Maintain records-center security, storage space, supplies, and equipment, including oversight of obsolete-record disposal.
• Serve as the primary contact for internal and external clients and coordinate with departments to meet information needs.
• Train staff on scanning, records-management tasks, policies, and procedures; may lead records-management projects and monitor daily outputs against deadlines.

Requirements

• High School Diploma or equivalent.
• 3–4 years of experience in a relevant clinical research environment, or an equivalent combination of education, training, and experience.
• Good knowledge of applicable clinical research regulatory requirements, including ICH, GCP, and relevant local laws, regulations, and guidelines.
• Knowledge of technology applications relevant to records-center environments, general computer technology, software programs, and accurate data entry.
• Attention to detail, accuracy, problem-solving ability, and the ability to maintain productivity under time pressure.
• Strong organizational, planning, decision-making, time-management, and prioritization skills.
• Extensive knowledge of records-management laws and regulations.
• Excellent oral and written communication skills, including good command of English; ability to establish effective relationships with internal and external clients.
• Ability to manage and lead others; significant writing, keyboarding, repetitive hand motions, and physical work involving sitting, standing, walking, reaching, stooping, kneeling, and lifting up to 40 pounds/18 kg.

Culture & Benefits

• Work supporting clinical research and healthcare intelligence in a global organization.
• Work may be performed in shifts.
• Responsibilities include collaboration with internal and external clients and training of team members.