TMF Specialist

About the role

IQVIA, a global provider of clinical research services, is looking for a TMF Specialist in Dalian. The role supports project execution through complex administrative and records management work, acting as the main contact for internal and external clients.

Key responsibilities

• Perform complex administrative tasks supporting team members and update and maintain project data within timelines and plans
• Coordinate retrieval of records and prepare closed studies for delivery, and act as primary contact for clients
• Manage scanning processes and train staff on them
• Monitor filing accuracy and compliance with IQVIA or customer file plans and SOPs, and maintain records centre security
• May coordinate transfer, recall and disposition of records to commercial storage centres, and oversee disposal of obsolete records
• Train team members on records management tasks, policies and procedures, and design and administer records management systems
• Ensure project deadlines and goals are met by monitoring daily outputs; may act as team leader for records management projects

Required profile

• High school diploma or equivalent, or an equivalent combination of education, training and experience
• 3-4 years of experience in a clinical research environment
• Good knowledge of ICH, GCP and relevant local laws and regulations, plus extensive knowledge of records management laws and regulations
• Ability to manage and lead others, and to build effective relationships with internal and external clients
• Position involves writing and keyboarding for long periods, standing, walking, stooping, kneeling and using a ladder; unaided lifting of up to 40 pounds (18 kg); shift work may be required

Required skills

• Knowledge of technology applications used in records centres and general computer skills with accurate data entry
• Attention to detail, problem-solving, planning, decision-making, time management and prioritisation
• Excellent oral and written communication skills, including a good command of English