Serve as the liaison between Records Management and user departments regarding Trial Master Files.Apply Records Management expertise to provide project related assistance across multiple project(s) and project teams. Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics. May be required to ensure that project timelines are met and facilitate the orderly scanning, transfer, retention, and disposition of various project-related and business records. May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. May manage a team of records management or technically-related staff working in support of projects within a designated office, country, or region.
• Serve as the liaison between Records Management and user departments regarding Trial Master files
• Apply Records Management expertise to provide project related assistance across complex and multiple project(s), sites, and project teams
• Ensure project deadlines, commitments, and goals are met by monitoring project’s daily outputs
• Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, meets quality and timeline metrics
• Serve as primary contact for internal/external clients
• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within the agreed timelines
• May assist management with the implementation of plans, cost proposals, and resource projections for records management projects
• Train team members on records management tasks, policies, and procedures
• Collect data and assist in the preparation of statistical reports for management of record center operations, as appropriate or as requested
• May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources
• May maintain accurate trackers and systems to control records and box inventory
• May coordinate transfer, recall, and disposition of records to commercial records storage centers
• May oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment
• Maintain records center security to protect record integrity by ensuring compliance to SOPs
• Bachelor's Degree Bachelor's Degree in health care or other scientific discipline or equivalent combination of education, training and experience. Req
• 4 years experience working in Records Management or technically-related area.
• Equivalent combination of education, training and experience.
• Advanced knowledge in Records Management or technically-related areas, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws and applicable regulatory guidelines.
• General knowledge of computer technology and software programs.
• Strong organizational, planning, and decision making skills.
• Excellent oral and written communication skills including good command of English language.
• Ability to perceive and analyze problems, develop solutions, and make sound decisions.
• Ability to lead others.
• Ability to establish and maintain effective working relationships with internal and external clients.
• Ability to achieve productivity despite time pressure constraints.
• Ability to handle multiple tasks and projects within defined timelines and balance competing priorities.
• Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
• May require occasional travels.