ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).

Responsibilities:

• Organizes and delivers analyzable reports and metrics to the clinical study lead

• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings

• Collates data for assessments such as feasibility and site selection and reviews site usability database

• Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures

• Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders

• Collates materials for training and investigator meetings

• Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan

• Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings

• Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance

• Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

• Manages and maintains team SharePoint and/or shared drive sites, as needed

• Communication with sites as directed and maintains site contact information

• Contributes to line listings review for Blind Data Review Meeting (BDRM)

• May manage or contribute to oversight of Third Party Vendors (TPV)

• Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits

• Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives

• Proactively recommends process improvement initiatives for the department

• May require 25% travel internally and externally

• Ability to be resourceful and to demonstrate problem solving skills

• Demonstrate the ability to proactively assess information and investigate impact on clinical trials

• Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF

• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

• Basic familiarity with medical terms and clinical drug development

• Awareness of ICH/GCP

Qualifications:

• Bachelor’s Degree

• Minimum 2+ years of CRO and/or Pharma industry related work experience OR an advanced degree in a related field with a minimum of one (1) or two (2) years of relevant work experience.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.