Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.
We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries.
We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

ICON plc

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project-manager

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.

We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

• support the Client Associate Director, Evidence Project Management I, II (AD EPM) in the operational delivery and oversight of company sponsored evidence (observational and externally sponsored) studies to time, cost and quality.
• work cross-functionally with internal and external partners to deliver certain aspects of the clinical study as delegated by the AD EPM
• support OBU Medical Evidence’s continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.

Evidence Project Manager

Evidence Project Manager at ICON plc supporting clinical study operations and collaborating cross-functionally with partners to deliver quality evidence. Driving improvements in medical affairs studies with a strategic mindset.

• The SUPM is responsible for delivering site activations to plan, for the SUPM I this can be for all sites for an entire study or a portion of sites in specific countries in one or more regions.
• As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete.
• Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study.
• Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership).
• Start up meetings use the ongoing risk assessment of site activation delivery to form a focused agenda according to risk level, the overall goal is the delivery of major study milestones to plan (e.g. first subject first visit) as well as the overall delivery of major site activations to plan (25%, 50% and 90% of planned site activations).
• The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study, they will do so while considering the relative priority of their study compared to all concurrent studies in start up that country level start up roles are working on.
• Act as a key point of escalations for site activation related issues raised by country level start up roles, seeking to firstly resolve issues directly or triage appropriately to other SUPMs on the study or the study management team, will always follow through to resolution.
• Responsible for the completeness and quality of site activation timeline plans for every site from investigator initiation package sent for first site in study, to site activation complete for last site in study.
• Will work with and drive all timeline plan owners (e.g. country start up roles) to actively manage the site activation timeline plans for their assigned sites.
• The SUPM will have a detailed understanding of the timeline for every site: Understanding the critical path activities for all sites based on specific needs of every site and their associated upstream country and study related tasks.
• Plan and execute the timely delivery of the investigator initiation package needed for investigational product release to site in partnership with document owners (particular country level roles), including incorporating the translation requirements into that plan.
• Work in lock step with specialist roles that work directly with sites on the study budgets and contracts to bring this key activity off the site activation critical path.
• Co-ordinate across all roles that work directly with site staff to complete site activation readiness tasks (system access and training, protocol related training) to time completion prior to the site initiation visit, or as soon as possible afterwards to reduce or eliminate from the site activation critical path.
• Work across roles responsible for the delivery of all physical supplies (investigational product and all non-clinical supplies) to plan and execute delivery to all sites in lock step with all other tasks required for site activation.
• Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders.

Start Up Project Manager

Start Up Project Manager overseeing site activations for clinical trials at ICON plc. Responsible for global study start up project strategy and leading cross-functional teams.

• Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
• May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
• Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
• Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
• Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
• Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
• Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
• Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
• Ensures compliance to relevant Global and Local, internal and external requirements and regulations
• Ensures timely communication bidirectionally between the global and local study team.
• Provides protocol level guidance and support to responsible Local Study Team members as applicable.
• Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
• Utilize roles in countries such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
• Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at the lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
• Follows up on region/country level issue status to ensure resolution.
• Identifies country level trends to improve deliverables processes as needed
• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
• Ensures audit/Inspection readiness during start-up and conduct
• Manages applicable Quality Events with pCRO and local team as applicable and required
• Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
• Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
• Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
• May act as a Subject Matter Expert
• May lead operational effectiveness initiatives at country or regional level
• Responsible for PTA and SIV report review for reports completed by the Site Care Partner
• Supports implementation of client’s Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
• Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
• Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
• Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
• Ensure pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
• Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
• Support Identification, contract development and management of local vendors or facilities as per protocol
• Investigator Meeting support and management including doing presentations as appropriate
• Management of local Investigator Meetings including doing presentations as appropriate

Project Manager

Project Manager overseeing study management and clinical trial activities at ICON. Ensuring compliance, timely communication, and stakeholder management in study execution.

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

ICON plc

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3 jobs found

Evidence Project Manager

ICON plc

Start Up Project Manager

ICON plc

Project Manager

ICON plc