Project Manager (Country Study Manager)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.

#LI-DD1

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply