Tmf Specialist

Job Title / Primary Skill: TMF Specialist
Years of Experience: 1- 5 Years
Job Location: Bangalore/Thane
Must Have Skills: eTMF, Veeva vault
Good to Have Skills: Veeva Vault

Note - Immediate joiners are preferred

Job Description

• Ensure project deadlines, commitments, and goals are met by monitoring teams daily outputs
• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to clients
• Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs)
• 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
• Monitor and assist in the preparation of closed studies for transfer to clients per agreed due dates
• Train team members on records management tasks, policies, and procedures
• Serve as primary contact for 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
• Conduct and manage processes and train staff on processes
• May function as team leader for records management projects

Educational Qualification:

• High School Diploma or equivalent Req
• 3 years' experience working in a Records Management environment. 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.
• 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 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.
• Regular sitting for extended periods of time.