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Trial Master File Owner

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About the role

This vacancy has now expired. Please click here to view live vacancies.

 
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.
 
Overview of the Role
  • 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

Job Functions/Responsibilities

  • 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

 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  Your dedicated recruiter will discuss this information with you during your phone interview.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer -  M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
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