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

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