Project Manager – Country Study Manager

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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.

📋 Description

• 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. • 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. • 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 • Identifies country level trends to improve deliverables processes as needed • Ensures audit/Inspection readiness during start-up and conduct • 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

🎯 Requirements

• 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.

🏖️ Benefits

• 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