Team Lead – TMF Operations
| Company | Alimentiv |
|---|---|
| Location | London, ON, Canada |
| Salary | $67500 – $112000 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior, Expert or higher |
Requirements
- 4-6 years of related experience
- (Honors) bachelor’s degree
- English language proficiency required
- Familiarity with the Trial Master File Reference Model and a demonstrated understanding of records management best practices
- Demonstrated understanding of TMF documents (content/flow) generated by different departments
- Possess a thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials and the management of TMF content
Responsibilities
- Provides management oversight of personnel and TMF Management activities for designated scope within TMF Operations
- Responsible for end-to-end delivery of TMF services and collaborating with internal and external customers
- Act as coach and Subject Matter Expert within the department
- Responsible for TMF Management for assigned studies and acts as point of escalation for TMF related issues and queries
- Communicate with study team members from study set-up through to TMF close-out and transfer/archival
- Lead TMF oversight discussions with stakeholders to optimize TMF management technology, processes, and standards
- Ensure TMF group meets timelines, provides high quality deliverables, complies with contractual project requirements for designated studies
- Coordinate and supervise the day-to-day work of the TMF Operations staff assigned
- Train and mentor assigned employees on Alimentiv procedures and guidelines
- Guide and coach individual goal setting and professional development
- Responsible for performance management of direct reports including career conversations and oversight of work for quality and compliance
- Review and approval of line reports’ leave requests, expense reports and other administration
- Facilitate new team member training and onboarding
- Assist management with interview and hiring process
- Ensure continuous improvement through education, feedback, and guidance to TMF Operations and stakeholders
- Propose and collaborate on department initiatives and strategies
- Support with management of TMF archival responsibilities
- May work with other departments on special projects/workstreams to create solutions to address business and operational challenges
- May support Business Development activities related to TMF Management
Preferred Qualifications
- 7-9 years of related experience
- Master’s degree
- Leadership and/or teaching abilities and experience (preferred)
- Cross-cultural work competency