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.
Services Overview:
Site Management services provides Trial Co-ordination and Site Management services as primary point of contact between the sponsor and the investigational site. Services/deliverables include ensuring trial sites are inspection ready through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), applicable regulations from start-up through data-base lock. Further, services/deliverables will include pre- trial assessment, site selection, subject recruitment and retention planning, site initiation, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Local Trial Manager (LTM) and Central Trial Manager (CTM)/Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols.
Deliverables:
• Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Complies with relevant training requirements.
• Contribute to quality Site Selection through participation in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team, as required.
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
• Drive study compliance by executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies. Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non-IP, lab kits, etc.) and clinical drug supplies. This will include oversight of proper handling, storage and return and/or destruction with accurate inventory maintained/documented.
• Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved within expected timelines.
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents.
• Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements, including storage in a secure area at
all times.
• Focuses on Investigator engagement through timely follow up with sites. Completes follow-up letter to communicate relevant information and required corrective action to the investigator and
his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders. Follows the corresponding Monitoring Guidelines for each assigned trial.
• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge sufficient for role and responsibilities.
• Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
• If applicable, will support negotiation of investigator budgets at site level, support tracking of costs and ensure payments are made at site level, maintaining site relationships.
• May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
• May contribute as a mentor to a less experienced site manager or to process improvement and training, as appropriate for business needs.
• Ensure timely and accurate CTMS data entries / updates.
• SMs may also take the role of Independent Drug Monitor (IDM) once additional training is completed and as required by individual trial.
• If applicable, region specific deliverables will be specified.
• Advanced:
o Autonomy in execution of site management services o Depth of knowledge with site management services
Education and Experience Requirements:
• BA/BS degree/Degree in a health or science related field or equivalent industry experience
• Minimum 1 year of clinical trial monitoring experience or equivalent industry experience and completion of a monitoring training course
• Specific therapeutic area experience depending on the services need.
• Strong working knowledge of ICH GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
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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 maximise 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 website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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, colour, 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.
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