Trial Master File Owner

• Responsible for the complete and accurate Trial Master Files through documentation of quality, consistency and timely filing across all clinical trials
• Responsible to ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.
• Responsible that the Trial Master Files are submission/inspection ready

• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 10%) domestic and/or international. AntiCipated activities may include attendance at client meetings, study team meetings or audits.
• Develops and assists with the implementation of the Trial Master File specifications ie. Regulatory packet requirements, blinded vs. unblended documentation and location
• Ensure Trial Master File project specifications are in alignment with program strategy and milestones
• Provide consistent setup and maintenance of TMF requirements and processes and programs
• Ensure that documentation flow for TMF documents meet the required timelines and intervene with action plans and follow up as appropriate
• Assist with internal and external audits related to the TMF processes and activities
• Assist with the development of corrective action plans related to TMF findings
• Review data quality outputs and audit outputs to identify trends per study and across programs
• Provide Lessons Learned information
• Comply with metrics established for performance TMF reviews
• Responsible to ensure that TMF documentation is complete prior to study close/submission
• Attend 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.

Role Requirements

• To perform this job successfully, an individual must be able to perform each essential duty

  satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• EU/APAC: Prior relevant experience and/or understanding of clinical study start up requirements and activities.

• Good organizational skills and the ability to manage multiple tasks.

• An excellent level and proven experience of high standards of attention to detail.

• Good written and verbal communication skills. Proficient in English and language required for country assignments.

• Ability to be customer focused is essential.

• Logical and critical thinking skills.

• Competent computer skills.

• Due to the nature of this position it may be required for the employee to travel. Therefore, dependent  on the employee's location, the employee may be required to possess a valid Driver's license.

Benefits of Working in ICON