At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

• In collaboration with the Support Services Manager, the Record Specialist (RS) will be responsible to oversee and monitor the quality and completeness of the local study files (paper and/or electronic) within the Cluster CSU countries (Spain and Portugal) to ensure audit and inspection readiness.
• This role will act as the subject matter expert locally and collaborate with the Global Record Management Team.
• The scope of the filing activities spans from study start up to final archiving.
• The RS will work with all file contributors within each study program (e.g., monitoring team, IMP Lead, Safety Lead (SL), Quality Lead (QL), System Expert (SE), etc) to ensure that all procedures, systems and timelines are being maintained.
• Some aspects of this role are to ensure that all Trial Master Files are maintained up to date and quality of Local Study Files documents/contents are periodically reviewed.

Main functions

• Training of applicable CSU staff on TMF procedures, systems and archiving expectations (paper and/or electronic) - in collaboration with other CSU roles (QL and SE) and Global Record Management.
• Use Global tools and reports to assess local TMF quality and completeness and follow-up with key stakeholders to ensure compliance.
• Perform and document regular quality control checks during studies to ensure document content and legibility of scanned documents to ensure inspection readiness.
• Participate in updating local filing quality documents as needed and - in collaboration with other CSU roles (QL and SE) and Global record Management team.
• Ensure accession checklist is accurate and completed on time for archiving deadlines (in collaboration with Global Record Management team timelines), and documents are shipped to final archiving location.
• Alert and escalate filing deviations/risks accordingly to CSU Management.
• Facilitate audit and inspection (including Pre-Approval Inspection) activities.
• Coordinate and collaborate with study team managers to identify employee training gaps or deficiencies (large group of internal, and/or contract employees with different levels of experience and technical skills)
• Reporting/escalating to line management any quality deviations/risks where remediation has been attempted and not been successful.
• Decisions are needed to plan and resolve process/system related issues for business continuity and efficiency for clinical related operational activities for internal and external employees. Strategic decisions should be made in consultation with CSU Management team and also supporting departments as applicable.
• Distribute Metrics received form corporate to the different MT teams pacticipating in the studies to ensure completeness of the eTMF.

Requirements

• Background: Bachelor’s degree (or equivalent). Must have 5 years of experience in a Pharmaceutical research environment. Training certification in adult learning (or equivalent) experience. Experience in Leading teams, project management.

• Knowledge: Must have a high level of understanding of information technology, and computer expertise (e.g., eTMF, demonstrated proficiency with MS Office applications, scanning, etc.) Clinical trial related experience with strong background in filing is a must. Possess strong organizational skills, training, coaching, and communication skills. Ability to understand and develop performance metrics for quality enhancement.

• Language (language and knowledge level ): English fluency, level advanced, spoken and written for communication with international teams.

• Professional experience: Five years of professional experience in Clinical Research mainly in Filing documentation and electronic training records..

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.