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:
To act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies. To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study for the delivery of all aspects of monitoring and site management, ensuring consistency with ICH/GCP and applicable ICON Standard Operating procedures (SOPs), applicable regulations, the Monitoring and ensuring the clinical portion of the study is inspection ready at all times. May also act as a single service project manager, or as a project manager for small studies.
- Recognize, exemplify and adhere to ICON's values which center on our commitment to people. Clients and Performance.
- As a Professional, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs. Actively identify opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices.
- Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders. May act as the primary point of contact for smaller or single service projects.
- Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management, timely investigator payments.
- Responsible for driving enrolment as per contracted timelines.
- Regular oversight of key clinical metrics, including but not limited to: Days on Site (DOS), Monitoring Visit reports (MVR) and Follow up Letters (FUL) timelines, Action items (Al) and other quality metrics, to ensure they are met and followed-up as necessary.
- Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and interacting with the Central Visit Report Approvers, as appropriate.
- Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner.
- Contribute to the development and maintenance of all clinical elements of cross-functional project plans. Able to work on multinational studies or take the role of a Global CTM.
- Responsible for co- coordinating, managing and mentoring the clinical project team to ensure high performance and productivity
- Active involvement in clinical risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation and resolution
- Responsible for the development and maintenance of operational plans e.g. for clinical deliverables CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training plan, annotated trip report etc.
- Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement ln archiving as necessary. This includes documented QC checks of in-house investigator site files.
- Ensure all closeout activities are completed as necessary e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved.
- Lead and/or actively participate in the conduct of clinical team memos.
- Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables.
- Implement QC activities, ensure compliance with quality measures, and monitor required quality metrics.
- Develop a succession plan for clinical study team members and, in the event of a change to the team, ensure an effective hand-over that is appropriately documented.
- Participate in the hiring interview process, if applicable.
- Maintain confidentiality of information, as appropriate.
- Participate in business development activities including bid defense meetings; may be required to provide input to the clinical strategy.
- May be required to undertake specific PM tasks, as agreed with Line Manager
- Participate in Company/Departmental Undertake other reasonably related duties as assigned
Core Responsibilities:
- Lead clinical resources in a matrix environment, as required, including Clinical Trial Assistants and Clinical Research Associates.
- Set expectations for the study team and drive a performance culture through their teams
- Develop staff skills, encourage career growth and provide regular performance feedback.
- Act as mentor and help to train junior staff.
- Communicate expectations, set clear goals and objectives for the study(ies) to clinical team members.
- Ensure teams are aware of progress to goals and against expectations.
- Lead by example and motivate all assigned team members.
What you need to have:
- B.A./B.S. with strong emphasis in science and/or biology preferred (but not required)
- Atleast 5 years clinical research experience with atleast 1 solid year being the Global Lead in a matrix environment
- Global experience required
- Vendor Management experience required
- Dermatology indications (i.e. Psoriasis) is a plus but not required
- Flexible for meeting times (some early in the morning to overlap with Europe/China simultaneously, and some evening to overlap with China).
- Travel (approximately up to 25%) domestic and/or international.
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
Pay Range ($130,856/yr – $163,570/yr)
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.
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.
