TMF Manager

  Medical Writing

Job title: TMF Manager

Company: IQVIA

Job description: JOB DESCRIPTION Job Overview Ensures 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. Manages the

JOB DESCRIPTION Job Overview Ensures 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. Manages the human, material, system, and fiscal resources to provide records management within a designated office, country, or region. Ensures that Records Management staff gain the necessary skills to perform their respective job responsibilities. May apply Records Management expertise to provide project related assistance across multiple project(s). May supervise and manage people managers who manage or support studies to ensure quality, time, and budget deliverables are met. Essential Functions . Manage staff in accordance with organization’s policies and applicable regulations . Responsibilities include planning, assigning, and directing work, appraising performance, guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems . Participate in the allocation of resources to projects by assigning staff to projects that are appropriate to their experience and training . Manage the quality of assigned staff’s work through regular review and evaluation of work product . Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by records management . Participate in records management quality or process initiatives including client audits . Approve actions on human resources matters . Lead the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process . Ensure that staff have the proper materials, systems access and training to complete job responsibilities . Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs . Provide oversight for the execution of the training plan, Standard Operating Procedure (SOP) review and mentored training experiences, as applicable . Assist to ensure consistency and global alignment of policies and procedures . Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff . Assist in identifying financial opportunities and performance efficiencies and implementing process improvements and cost saving ideas Qualifications . Bachelor’s Degree Bachelor’s Degree in health care or other scientific discipline or equivalent combination of education, training and experience Req . At least 5 years’ experience working in clinical research 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

Expected salary:

Location: Thane, Maharashtra

Job date: Thu, 09 Jun 2022 22:20:31 GMT

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