POL-HB-PM
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.
Project Manager will have responsibilities for study on country level activities from study startup through conduct and study close. Project Manager will be assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, other PMs and the larger Study Management delivery of the study.
Project Manager has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. Project Manager may lead specific parts of the project or drive specific countries. They may help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks. They will ensure the operational delivery of responsible tasks within one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable. Project Manager may be responsible to independently take on activities with instruction provided as needed. They may lead and guide the closing out of one or more studies of low complexity post database lock.
What will you do:
Country/Study level implementation of Startup and Site Activation Plans
Country/Study level Recruitment Strategy
Responsible to support the development of study level plans
Communication with the local team and internal stakeholders and CRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.
Project Manager will be able to work independently and exercise their own judgement.
Responsibilities
Operational Study Management
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 and/or oversee CRO responsible for these activities as applicable
Through the Site Care Partner/Country Trial Manager or CRO 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
Is accountable for overseeing CRO and/or Project Manager/Site Engagement Liaison 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.
Leader of the Local Study Team
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 the team to agree on submission strategy to Health Authorities and Ethic Committees
Utilizes roles in country 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 lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
Follows up on 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 Engagement Liaison
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 CRO 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
Ensures CRO 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
Your Profile:
Bachelor or Master degree
At least 2-3 years on the similar position as Local Trial Manager in CRO or Pharmaceutical Industry
Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
English is required.
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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 maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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
