ICON Strategic Solutions
Clinical Study Specialist (Office-based - Warren, NJ)
ICON Strategic Solutions, Basking Ridge, New Jersey, us, 07920
Overview
Clinical Study Specialist (Office-based - Warren, NJ) role at ICON Strategic Solutions. This title appears multiple times in the original description; this refined version presents a single, clear overview suitable for candidate applications. ICON plc is a world-leading healthcare intelligence and clinical research organization. We 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. Responsibilities
Organize and deliver analyzable reports and metrics to the clinical study lead. Schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings. Collate data for assessments such as feasibility and site selection and review site usability databases. Contribute to the review of study documents such as informed consent forms and case report forms; facilitate study document reviews per company standard operating procedures. Compile study manuals (e.g., study reference binders and manuals) and maintain versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders). Collate materials for training and investigator meetings. Track site activation, enrolment, and monitoring visits against projected plans; escalate issues or delays with site activation or deviations from the monitoring plan. Monitor and update investigator/site status for the trial and support clinical trial registry postings. Perform scheduled reconciliations of the Trial Master File (TMF) with guidance from the clinical study lead. Ensure scheduled reports are received (e.g., 1572 changes, financial disclosure forms). Manage and maintain team SharePoint and/or shared drive sites as needed. Maintain communication with sites and keep site contact information up to date. Contribute to line listings review for Blind Data Review Meeting (BDRM). May manage or contribute to oversight of Third Party Vendors (TPV). Track and monitor close-out activities (e.g., 1572s, Investigational Product reconciliation, Financial Disclosures) and CRA close-out visits. Participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives. Proactively recommend process improvement initiatives for the department. Qualifications
Must have a Bachelor's Degree. Must have a minimum of 2 years of industry-related work experience. Experience supporting global trials (NA, LAM, EU, APAC, India). Experience working in TMF, CTMS, and SharePoint. Excellent written and verbal communication skills. Self-starter; able to work independently with minimal oversight; solution-oriented. ICF review experience. General competency in PowerPoint and Excel; meeting minutes preparation. Vendor management/oversight experience is a plus. Must be open to hybrid office/home-based in Warren, NJ or Armonk, NY. What ICON Can Offer You
Our success depends on the quality of our people. We’ve built a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance for you and your family. Benefits Examples
Various annual leave entitlements. A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings. Global Employee Assistance Programme (LifeWorks) with 24-hour access to a global network of professionals. Life assurance. Flexible country-specific optional benefits (e.g., childcare vouchers, gym memberships, subsidized travel passes, health assessments). Visit our careers site to read more about the benefits ICON offers. ICON is committed to inclusion and belonging, providing an inclusive and accessible environment for all candidates. 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 you need a reasonable accommodation for any part of the application process, please let us know. If you are interested but unsure if you meet all requirements, we encourage you to apply—there’s every chance you’re exactly what ICON is looking for. Are you a current ICON employee? Please click here to apply. Seniority level
Entry level Employment type
Full-time Job function
Health Care Provider Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at ICON Strategic Solutions by 2x.
#J-18808-Ljbffr
Clinical Study Specialist (Office-based - Warren, NJ) role at ICON Strategic Solutions. This title appears multiple times in the original description; this refined version presents a single, clear overview suitable for candidate applications. ICON plc is a world-leading healthcare intelligence and clinical research organization. We 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. Responsibilities
Organize and deliver analyzable reports and metrics to the clinical study lead. Schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings. Collate data for assessments such as feasibility and site selection and review site usability databases. Contribute to the review of study documents such as informed consent forms and case report forms; facilitate study document reviews per company standard operating procedures. Compile study manuals (e.g., study reference binders and manuals) and maintain versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders). Collate materials for training and investigator meetings. Track site activation, enrolment, and monitoring visits against projected plans; escalate issues or delays with site activation or deviations from the monitoring plan. Monitor and update investigator/site status for the trial and support clinical trial registry postings. Perform scheduled reconciliations of the Trial Master File (TMF) with guidance from the clinical study lead. Ensure scheduled reports are received (e.g., 1572 changes, financial disclosure forms). Manage and maintain team SharePoint and/or shared drive sites as needed. Maintain communication with sites and keep site contact information up to date. Contribute to line listings review for Blind Data Review Meeting (BDRM). May manage or contribute to oversight of Third Party Vendors (TPV). Track and monitor close-out activities (e.g., 1572s, Investigational Product reconciliation, Financial Disclosures) and CRA close-out visits. Participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives. Proactively recommend process improvement initiatives for the department. Qualifications
Must have a Bachelor's Degree. Must have a minimum of 2 years of industry-related work experience. Experience supporting global trials (NA, LAM, EU, APAC, India). Experience working in TMF, CTMS, and SharePoint. Excellent written and verbal communication skills. Self-starter; able to work independently with minimal oversight; solution-oriented. ICF review experience. General competency in PowerPoint and Excel; meeting minutes preparation. Vendor management/oversight experience is a plus. Must be open to hybrid office/home-based in Warren, NJ or Armonk, NY. What ICON Can Offer You
Our success depends on the quality of our people. We’ve built a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance for you and your family. Benefits Examples
Various annual leave entitlements. A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings. Global Employee Assistance Programme (LifeWorks) with 24-hour access to a global network of professionals. Life assurance. Flexible country-specific optional benefits (e.g., childcare vouchers, gym memberships, subsidized travel passes, health assessments). Visit our careers site to read more about the benefits ICON offers. ICON is committed to inclusion and belonging, providing an inclusive and accessible environment for all candidates. 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 you need a reasonable accommodation for any part of the application process, please let us know. If you are interested but unsure if you meet all requirements, we encourage you to apply—there’s every chance you’re exactly what ICON is looking for. Are you a current ICON employee? Please click here to apply. Seniority level
Entry level Employment type
Full-time Job function
Health Care Provider Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at ICON Strategic Solutions by 2x.
#J-18808-Ljbffr