Clinical Study Specialist

ICON Strategic Solutions; Cambridge (Lancaster County); Hybrid; USD 85,000 - 120,000; Full time

Job summary

ICON plc is seeking a Clinical Study Specialist for a hybrid role in the United States. You will organize reports, coordinate meetings, and support TMF, CTMS, and site activation activities. The role requires a Bachelor’s degree and 2+ years in clinical research.

You will work with global trial teams (NA, LAM, EU, APAC, India) and engage in vendor oversight, data preparation, and training material curation. This position offers hybrid office/home flexibility in select US locations.

Qualifications

• Bachelor's degree required.
• Minimum 2 years of industry-related experience.
• Experience supporting global trials (NA, LAM, EU, APAC, India).
• Experience working in TMF, CTMS, SharePoint.
• Excels in written and verbal communications.
• Self-starter, can work independently with minimal oversight, solution-oriented.
• Vendor management/oversight experience a plus.
• Open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA.

Responsibilities

• Organizes and delivers analyzable reports and metrics to the clinical study lead.
• Schedules and coordinates meetings, prepares agendas, materials and minutes for study meetings.
• Collates data for assessments (feasibility and site selection) and reviews site usability database.
• Reviews study documents (informed consent forms, case report forms) and supports SOPs.
• Compiles study manuals and maintains versioning of reference materials.
• Gathers materials for training and investigator meetings.
• Tracks site activation, enrolment and monitoring visits and escalates issues.
• Monitors investigator/site status and supports registry postings.
• Performs TMF reconciliations with study lead guidance.
• Ensures receipt of required reports (e.g., 1572 changes, disclosures).
• Manages SharePoint/shared drives and site contacts.
• Contributes to BDirections and data reviews as needed.
• May oversee third-party vendors and close-out activities.

Skills

PowerPoint

Excel

Communication

Vendor management

SharePoint

CTMS

TMF

Education

Bachelor's Degree

Tools

TMF

CTMS

SharePoint

Job description

Clinical Study Specialist (Hybrid) ICON plc is a world-leading healthcare intelligence and clinical research organization. We7re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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 (NA, LAM, EU, APAC, India)
• 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

What ICON Can Offer You

Our success depends on the quality of our people. Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. Were dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – theres every chance youre exactly what we re looking for here at ICON whether it is for this or other roles.

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