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Manager, Tmf Operations

2+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager - TMF

Location: Chennai (Office-based)

Company: ICON plc

About Us: ICON plc is a world-leading healthcare intelligence and clinical research organization. We are dedicated to fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development!

Position Overview: As a Manager in the TMF (Trial Master File) department, you will play a crucial role in managing document management activities for internal and client services. You will ensure adherence to ICON’s values while promoting a culture of process improvement and efficiency.

Key Responsibilities:

  • Embrace and exemplify ICON's values centered around People, Clients, and Performance.
  • Create a culture of process improvement focused on streamlining operations and adding value to our business.
  • Travel as needed (approximately <25%) for domestic and/or international engagements.
  • Manage document management departmental activities in line with client and study requirements, ICON SOPs/WPs, and applicable regulations.
  • Coordinate activities of Document Management staff on projects and generate status reports for ICON and clients.
  • Train, mentor, and manage staff, ensuring compliance with training requirements.
  • Develop study-specific procedures and manage multiple clients and projects simultaneously.
  • Liaise with study teams and Document Management staff to meet service commitments and quality targets.
  • Evaluate business processes for effectiveness, recommend improvements, and implement changes as directed.
  • Ensure appropriate maintenance of document files and storage areas according to ICON and client requirements.
  • Track activity/status in accordance with department and client requirements, including quality control and archiving.
  • Manage quality control activities and inform management of any training or quality issues.
  • Participate in audits and manage internal and external client requests as necessary.
  • Handle special projects or duties as requested by the department head.

What ICON Can Offer You: Our success is driven by the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, ICON offers a comprehensive benefits package focused on well-being and work-life balance, including:

  • Various annual leave entitlements.
  • A range of health insurance offerings tailored to your needs.
  • Competitive retirement planning options.
  • Global Employee Assistance Programme providing 24-hour support.
  • Life assurance and flexible optional benefits.

To learn more about our benefits, visit our careers site.

Diversity and Inclusion: ICON is an equal opportunity and inclusive employer 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.

If you require reasonable accommodations during the application process, please let us know or submit a request here.

Interested but Unsure? If you’re interested in this role but don’t meet all the requirements, we encourage you to apply—there’s a chance you might be exactly what we’re looking for!

Current ICON Employees: If you are a current ICON employee, please click here to apply.