(A) TMF Specialist II

Trial Master File Owner

Location – Poland

Our Trial Master File Owner plays a key role in ensuring the completeness and accuracy of the Trial Master Files(TMFs).  This is accomplished  through supporting study teams in meeting the sponsor’s standards of quality, consistency and timeliness in TMF documentation. .  Verifying that the clinical trial documentation is consistent with the TMFspecifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.  The TMF Owner role provides the study team an ongoing resource in maintaining the inspection-readiness of a protocol throughout the life of the trial.

Overview of the Role

• 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.
• Work with Project Managers to setup the TMF for each study to meet the specific needs of the team in terms of what documentation will be expected throughout the life of the study.
• Maintain the accuracy of the TMF through study team meetings and communications
• Generating reports detailing the documents coming and past due for a protocol to support the study team in achieving metrics established by the sponsor to measure TMF performance.
• Proactively provide feedback to your teams in terms of how the quality and timeliness of submissions can be improved through analysing trends.
• Ensure study teams are familiar with processes and procedures surrounding the setup and use of the sponsor’s eTMF
• Enforce document due dates by following up with study team members for outstanding items and develop corrective action plans related to TMF findings.
• Assist with internal and external audits
• Responsible to ensure that TMF documentation is complete prior to study close/submission
• Be familiar with ICH GCP, relevant country regulations/guidelines and ICON/sponsor SOPs.
• Undertake other reasonably related duties as may be assigned from time to time.

Role Requirements

• High School diploma, or local equivalent, required.  Bachelor’s degree, or local equivalent, preferred
• Minimum of 1 year 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.

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.

*LI-PW1