Clinical Study Specialist

ICON plc • Cambridge, MA

13d • Hybrid

About The Position

Clinical Study Specialist (office based) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re 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. That’s why we’ve 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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. We’re 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 – there’s every chance you’re 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 ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Requirements

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

Nice To Haves

• Vendor management/oversight experience a plus

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

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees