Manager, TMF Operations

Manager - TMF Operations / Chennai / Office-based

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Job Description:

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

• As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

• *To manage TMF Operations departmental activities for internal services or client services in accordance with client and study requirements, ICON SOPs/WPs and regulations, where applicable. This would include but is not limited to:

• coordinating TMF Operations staff activities on the project

• generating status reports for ICON and clients

• training, mentoring and managing staff

• liaising with Corporate Training and Development to ensure training is completed in compliance with ICON and/or client requirements and assisting with curriculum development where necessary

• developing study-specific procedures

• managing multiple clients and projects •

*To liaise with study teams and other TMF Operations staff in order to ensure service/contractual commitments and quality targets met and to provide guidance to department and study teams for study file archiving activities.

• To complete departmental projects as assigned in accordance with specified timelines, ICON SOPs/WPs and regulations.

• *To evaluate business processes and procedures for effectiveness and efficiency, make recommendations to the department head for improvements and implement agreed changes.

*To develop and implement new business processes as directed by the department head.

• *Ensure document record and filing supplies ensuring adequate supplies are available to TMF Operations staff.

• *To ensure appropriate maintenance of document files and storage areas in accordance with ICON and/or client requirements and SOPs/WPS and applicable regulations as directed by the department head.

• *To ensure activity/status tracking is completed in accordance with department/client requirements. Tracking includes: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.

• *To manage client and/or departmental status reporting as requested.

• *To manage all quality control activities for department.

• *To inform department management of training issues, project activities, quality issues and timelines as directed.

• *To manage internal and external client requests.

• *To participate in client and/or ICON audits as necessary.

• *To coordinate document archiving activities as necessary.

What You Need:

• 12+ years of overall experience

• Minimum 5 years of experience in TMF Operations and 3+ years of People Management experience.

• Knowledge or experience of automating the eTMF filing.

• Knowledge or experience of implementing BOTs.

• Familiarity with AI/ML applications in TMF Process.

• Strong understanding of various eTMF systems and other clinical systems.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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