Manager, TMF Operations

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The Manager of the Trial Master Owner Group will serve as the Functional Lead for Clinical Operations with responsibility for the delivery of inspection ready Trial Master Files (TMF), ensuring consistency and timeliness of required documents in accordance with defined SOPs, processes and metrics. The Manager will also be responsible ensuring that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements and that all Trial Master Files are submission/inspection ready.

Overview of the Role

• Management oversight to ensure timely, consistent and quality setup and maintenance of TMF requirements and processes and programs
• You will ensure that the staff is appropriately trained in systems, processes and SOPs and assign and prioritize workload, to deliver quality and timely output.
• Develop successful working relationships with clients; both internal and external.
• Responsible for risk mitigation strategies, associated action plans and issue resolution.
• You will manage TMF Operations in accordance to contractual agreements and proactively communicates changes, updates, issues to senior management.
• In conjunction with Document Management Leadership and TMF Operations Group, develop and oversee TMF activities for audits, questions and issues and action plans.
• Oversight for internal and external audits related to the TMF processes and activities.
• Management oversight for the development and timely resolution of corrective action plans related to TMF findings.
• Develop lessons learned and share across programs and therapeutic areas.
• Review data quality outputs and audit outputs to identify trends; develop process improvements.
• Review and report metrics established for performance TMF reviews and provide action plans as appropriate.
• Track TMF deliverables using appropriate tools.
• Develop TMF staff, ensure successful succession planning.
• Maintain confidentiality of management information as appropriate.
• Attend/conduct study team meetings as required.
• Be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs.
• Undertake other reasonably related duties as may be assigned from time to time.
• 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.
• Travel (approximately 5%) domestic and/or international.

Role Requirements

• You will possess minimum of 10+ year experience and/or understanding of clinical study start up requirements and activities and hold a Bachelor's degree, or local equivalent, preferred in medicine, science or equivalent degree/ experience.
• 2+ years of people management experience is mandatory (managing 20-30 team members)
• Excellent organizational skills, the ability to manage multiple tasks and proven experience of high standards of attention to detail.
• Excellent written and verbal communication skills. Proficient in English and language required for country assignments.
• Ability to be customer focused is essential.
• You will possess critical thinking and problem solving skills, conflict management and competent computer skills.
• Due to the nature of this position it may be required for the employee to travel.