Manages TMF Operations staff including TMF Document Assistants, TMF Document Specialists, TMF Compliance Specialists TMF Analysts and/or TMF Leads. Oversees study assignments for TMF Operations staff. Monitors staff performance and regularly meets with employees to discuss performance. Conducts performance appraisals at designated time points throughout the year and directly supports staff professional development. Participates in the interviewing and selection process and provides ongoing support during the onboarding phase. Ensures staff adhere to the quality expectation and participates in process improvement efforts for the department.
- Participates in and directs activities related to department staff operations such as interviewing and selection, professional development, training, performance management, and employee counseling and separations.
- Conducts courses of action on interviewing and selection, terminations, professional development, performance appraisals and employee counseling.
- Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods.
- Assigns resources and manages transitions of ongoing studies/processes/workflows.
- Manages periodic and ongoing compliance to quality and performance standards of direct reports.
- Ensures successful delivery of the TMF Operations Key Performance Indicators for direct reports.
- Ensures staff utilization meets department goal, reviews and approves timecards/expenses by established deadline and reviews and ensures staff training compliance.
- Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF.
- Designs and/or delivers TMF training in various formats via teleconference, video conference, and/or in person.
- Actively involved and/or leads department and business unit improvement initiatives.
- Coordinates with staffing vendor to manage temporary and/or flexible workforce, as applicable.
- Controls access to the Document Control Room according to applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs). Responsible for maintenance of the physical space in the Document Control work area, as applicable.
- Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Min 10 years in TMF / Regulatory records management in a global environment
Direct line management of 15 to 20 staff is must
Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
Demonstrated leadership skills.
Strong verbal, written, and organizational skills with a team-oriented approach.
Proficiency in Electronic Document Management Systems, web-based systems, Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Primary Location Asia Pacific - IND-Gurgaon-Cyber-City
Job Clinical Monitoring
Employee Status Regular