Study Start Up Associate II

Study Start Up Associate II 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. As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include: Work directly with assigned sites on all site related essential document collection and review. Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes. Ensure standards are applied to the SSU processes across projects. Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc Promptly recognize and improve potential site activation delays and escalate to appropriate team members. Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned. Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team. Review and provide feedback to management on site performance metrics. Ensure accuracy and completeness of the eTMF for assigned sites during start up Your Profile: You will bring relevant site start-up and activation experience, along with the following qualifications and skills. Required qualifications and experience: BS degree or international equivalent 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor. Ability to explain data to facilitate decision making processes to be data driven. Knowledge and understanding of clinical study protocols and essential documents Strong organizational skills, decision making, communication and negotiation skills Proficient in Microsoft Excel, Word, and PowerPoint. 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

You will lead clinical trial initiation activities, including site document collection, review, and activation. Additionally, you will collaborate with internal teams and CROs to ensure process compliance and resolve site-related delays.

Candidates must hold a bachelor's degree or international equivalent and possess at least 2 years of experience in clinical research site start-up. Proficiency in Microsoft Office and strong organizational and communication skills are required.

• Competitive base salary • Performance related incentives • Medical coverage • Dental coverage • Vision coverage • Retirement plans • Pension plans • Life assurance • Disability coverage • Employee assistance programmes • Wellbeing resources • Learning and development opportunities

• Analyse de donnéesSouhaitée
• Microsoft ExcelSouhaitée
• CommunicationSouhaitée
• Microsoft WordSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical research
• Study start up
• Site activation
• Regulatory compliance
• Document collection
• Clinical operations
• Data analysis
• Decision making
• Communication
• Negotiation
• Microsoft Excel
• Microsoft Word
• Microsoft PowerPoint
• eTMF
• Clinical study protocols
• Business Metrics
• Organizational Skills
• Management
• Decision Making
• Clinical Research
• Clinical Trials
• Innovation
• Operations
• Performance Metric
• Pharmaceuticals
• Regulatory Requirements
• Timelines

• Healthcare
• Science & Research
• Administrative
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• Clinical Research Coordinators
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Formation minimale

Baccalauréat

Expérience minimale

2+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine