IQVIA Hiring for TMF Manager at Pune, India Full Time

Job Overview

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), sites, and project teams. 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. 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. May manage a team of records management or technically-related staff working in support of projects within a designated office, country, or region.

Essential Functions

• Apply Records Management expertise to provide project related assistance across complex, multiple project(s), and project teams

• Serve as the liaison between Records Management and user departments regarding Trial Master files

• Serve as primary contact for internal/external clients

• 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, and meets quality and timeline metrics

• Maintain records center security to protect record integrity by ensuring compliance to SOPs

• Collect data and assist in the preparation of statistical reports for management of record center operations, as appropriate or as requested

• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within the agreed timelines

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

• May assist management with the implementation of plans, cost proposals, and resource projections for records management projects

• 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

Qualifications

• Bachelor’s Degree Bachelor’s degree in a health care or other scientific discipline or educational equivalent

Req

• At least 5 years’ experience working on Records Management or technically-related areas with 3 years’ experience in a leadership capacity. 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.

• Effective time management skills and ability to manage competing priorities.

• Ability to perceive and analyze problems, develop solutions, and make sound management decisions.

• Ability to achieve productivity despite time pressure constraints.

• Ability to handle multiple tasks and projects within defined timelines and balance competing priorities.

• Strong leadership skills.

• Ability to establish and maintain effective working relationships with coworkers, managers and internal and external clients.

• Ability to support and mentor Supervisors and Associate Managers.

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.

• Strong written and verbal communication skills including good command of English.

• Excellent organizational and problem solving skills.

• 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.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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