• The Sr. CTM is the lead operational contact for the study and provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. • Responsible for all operational aspects and progress of assigned clinical trial from a study planning activity to study execution including ongoing tracking all applicable performance metrics and quality indicators for milestone deliverables • Provide expertise and operational input into protocol synopsis, final protocol and other study related documents • Participate in country and site feasibility/selection process • Create and maintain timelines to meet the needs of the assigned clinical study(ies) • Ensure new team members and vendors are onboarded • Lead the development of the operational strategy in preparation for review; focus on ensuring accurate assumptions are applied and risk management plans are in place • Provide guidance to CRO/vendor to ensure study issues are addressed and resolved • Work to ensure that budgets, enrollment, and gaiting are maintained and accurate; communicate study status, cost and issues to Project Leader(s); serve as escalation point for vendors or other CROs • Support CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted • Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages • Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring • Review and endorsement of relevant study plans, as applicable • Study team meeting management and attendance; regular review of meeting agendas and minutes • Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study • Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies • In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR • Ensure studies are "inspection ready" at all time; may be involved in regulatory inspections by preparing for and attending the inspections • Represent Clinical Operations Manager role in functional projects or working groups • Help with onboarding and mentoring of new Clinical Operations Team members • Participates in the development, review, and implementation of departmental SOPs, initiatives and processes • Reviews/approves vendor invoices for all clinical trial vendors including investigative sites

• Provides operational support to the program lead to ensure project milestones delivery on time, within budget, with high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines and applicable SOPs. • Manage essential clinical trial duties and responsibilities as independently as possible, with guidance and oversight provided by leadership when needed. • Responsible for all operational aspects and progress of clinical trial from study planning activities to study execution including ongoing tracking of performance metrics and quality indicators. • Serves as an escalation point and resource for study team and investigational sites. • Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders. • Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Clinical Study Report (CSR) development, etc. • Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate. • Responsible for and participates in clinical vendor selection process as a part of outsourcing activities. • Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations). • Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages. • Creates, manages, measures, and reports timelines for milestone deliverables. • Oversees/facilitates site feasibility/selection processes. • Develops/oversees subject recruitment/retention strategy and related initiatives. • Oversees internal team meetings, investigator meetings, and other trial-specific meetings. • Participates in the development, review, and implementation of departmental SOPs, initiatives and processes. • Reviews/approves vendor invoices for all clinical trial vendors including investigative sites.

Clinical Study Lead 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 - Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives of individual protocols/programs. - Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial. - Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. - Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure. - Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight. - Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines. - Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met. - Supports financial management of the study which includes review and approval of site and vendor invoices. - Supports risk Management initiatives - Supports audit/inspection activities as needed. - Maintain clinical trial registry entry/updates, as required. - Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements. Your profile - Undergraduate degree or its international equivalent preferably in clinical, science, or health related field from an accredited institution; a licensed health-care professional, i.e., registered nurse - 5 years of relevant experience - Minimum 3 years of experience in clinical research, including a management role as a team lead or project manager experience. - Reads, writes and speaks fluent English; fluent in language of host country. 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

Make a difference. Be happy. Grow your career. SENIOR CONSULTANT - STAFFING SERVICES The Senior Consultant - Staffing Services provides expert platform-specific services leveraging their technical, management, and leadership skills to ensure success and aide their client in meeting their organizational goals. Key Responsibilities Perform professional services for Nordic and its affiliates in alignment with the expectations of Nordic and each applicable client, including but not limited to: - Evaluate current-system processes and procedures; recommend and develop workflow and computer system configurations and modifications based on experience and best practice - Apply technical expertise to individual client system build to identify, test, and troubleshoot software systems - Provide project management and project leadership services in alignment with client expectations and contracted role - Provide leadership guidance and mentorship to client and Nordic teammates - Work directly with project teams, end-users, and leadership as project needs dictate - Lead and attend meetings regarding project status and on-going work-product coordination - Accurately and completely document work progress, issues, escalations, and other required information in accordance with Nordic and individual client requirements - Additional specific duties related to the project as may be required and dictated by client Skills and Experience - Bachelor’s degree or equivalent experience required - Relevant training, certification, or accreditation required - 3+ years’ MEDITECH system build experience required - 5+ years’ professional experience strongly preferred - Previous consulting experience preferred - Excellent communication skills, written and verbal - Proven ability to apply problem solving and technical skills - Must demonstrate and embody Nordic’s maxims - Possess a strong work ethic and treat others with respect, keep commitments, inspire the trust of others, work ethically and with integrity, and uphold organizational values - Strong attention to detail and ability to manage multiple priorities while meeting customer service commitments and project timelines - Demonstrated sound judgment and appropriate escalation - Highly organized, able to multi-task as well as maintain intense focus on individual tasks - Self-starter with ability to maintain schedule, meet deadlines, and monitor one’s own work product - Highly adaptable and able to acclimate quickly to new project assignments - Aptitude for mentoring and guiding others - Maintain a high degree of professionalism - Must be able to work independently, as well as within a team environment Additional Details - Work may be performed remotely or onsite in a professional office environment, healthcare, or other industry-specific facility - Travel up to 100% of the time, or as Nordic or client needs dictate - Position generally necessitates travel outside of scheduled work hours including nights or weekends; travel interruptions may occur - Work schedule will vary based on Nordic or client needs, and may include weekdays, weekends, holidays, after-hours, on-call, or long hours - Must be available for calls, emails, and consults regularly and outside of scheduled work hours to support the client and communicate with Nordic staff as necessary - Timely entry of time and expenses required in accordance with Nordic and client policy - Status reporting and project handoff documentation as required by Nordic or client - Provide equipment necessary to perform job functions in accordance with Nordic and client policy - Complete all Nordic and client required training and education in timely manner - Respond to communication from Nordic management team and other corporate team members in a timely and complete manner - May be invited to attend corporate functions as a representative of the company to meet prospective consultants, as well as solidify relationships with client and Nordic co-workers Nordic is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, genetic information, marital or veteran status, or any other protected status under applicable federal, state, or local laws. We encourage individuals of all backgrounds to apply, including women, minorities, individuals with disabilities, and veterans.