TMF Quality Project Manager

Job Overview
Serve as the liaison between Records Management and user departments regarding Trial Master files. Apply clinical research Records Management expertise to provide project related assistance across multiple project(s) sites 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 lead teams functionally where assigned including awareness of scope of work budget and resources.

Essential Functions
Ensure that project timelines are met and facilitate the orderly transfer imaging scanning retention and disposition of various project-related and business records
Ensure all work is conducted in accordance with SOPs policies and practices good clinical practices and applicable regulatory requirements and meets quality and timeline metrics
Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within agreed timelines
Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs);
Conduct and manage imaging/scanning processes and train staff on imaging/scanning processes
Maintain records center security to protect record integrity by ensuring compliance to SOPs
Interface with departments to support retrieval projects and ensure information needs are met
Train team members on records management tasks policies and procedures
Serve as primary contact for internal and external clients
Coordinate transfer recall and disposition of records to commercial records storage centers
Oversee 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
Bachelors Degree Records management or related field Req
At least 4 years experience working in a Records Management technically-related area. Equivalent combination of education training and experience.
Strong knowledge of applicable research and regulatory requirements Conference on Harmonization (ICH) Good Clinical Practice (GCP) and relevant local laws regulations and guidelines.
Knowledge of technology applications relevant to records management environments.
Ability to perceive and analyze problems develop solutions and make sound decisions.
Ability to handle multiple tasks and projects within defined timelines and balance competing priorities.
Ability to remain focused with regards to details under pressure.
Strong organizational planning and decision making skills.
Excellent oral and written communication skills including good command of English language.
Ability to establish and maintain effective working relationships with nternal and external clients.
Ability to lead others.
Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
Regular sitting for extended periods of time.

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