Senior Records Management Associate/Records Management Analyst 1

Job Overview

Provide Trial Master File (TMF) - Quality checks related assistance to study teams. 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

• Perform assigned complex administrative tasks to support team members with project execution

• Assist in updating and maintaining complex data in systems within project timelines and per project plans

• Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs);

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

• Establish and maintain effective internal and external client communications

• Design and administer records management systems and processes

• Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs

• 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

• Bachelor's Degree Records management or related field.

• 3-4 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, i.e.,International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines.

• Knowledge of technology applications relevant to records management environments.

• General knowledge of computer technology and software programs, and accurate data entry skills.

• 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.

• Attention to detail and accuracy in work.

• 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 internal 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.