Clinical Study Specialist

• Clinical Study Specialist (Hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA)
• ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

What you will be doing

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

Your profile

Must have a Bachelor's Degree

Must have a minimum of 2 years industry related work experience

Experience supporting global trials (preferred)

Experience working in TMF, CTMS, Sharepoint,

Excels in written and verbal communications

Self-starter, can work independently with minimal oversight, solution-oriented

ICF review experience

General competency: powerpoint/excel skills, meeting minutes

Vendor management/oversight experience a plus

Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• •Competitive base salary and performance related incentives
• •Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• •Retirement and pension plans
• •Life assurance and disability coverage
• •Employee assistance programmes and wellbeing resources
• •Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here .

Salary Range

$62,376.00-$77,970.00

Are you a current ICON Employee? Please click here to apply