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As a Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**What you will be doing**:- Manages start-up activities for assigned studies at the regional level including supporting site identification/site recruitment/site selection, central and local submissions, site contracts, essential document preparation, Investigational Product (IP) release, site initiation visits (SIVs) readiness, and overall regional site activation readiness to ensure deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations.- Ensures that clinical delivery project team members and any other cross-functional team members needed to support regional site activations understand responsibilities and performance standards. Reviews metrics and other information sources to monitor team and individual performance, providing feedback to individual and functional manager (FM) as appropriate.- Communicates effectively with project team members to ensure alignment of study start-up strategy and risk mitigation. Selects appropriate communication platforms to convey information effectively and efficiently. May present at intra-/inter-departmental meetings.- Ensures quality standards and applicable regulatory requirements are met, in accordance with the protocol, applicable guidelines and local regulations for IP release and site activations.- Monitors regional resource allocations for study start-up team members. Consults with study start-up project leaders and escalates as needed.- Identifies and escalates potential risks with the regional start-up activities and deliverables, inclusive of proactive mitigation planning.- Conducts analysis of regional start-up risks and issues, acting and documenting in the appropriate system. Escalates as appropriate through functional management and study start up manager.- Analyzes metrics and reports of regional performance against key performance indicators.**You are**:- Bachelor’s degree in a business-related, health, life sciences or other relevant field of study.- Broad experience and knowledge with Mexico ethical submissions (Digipriss) for start-up studies.- Experience in CRO or pharma company.- Read, write, and speak fluent English**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 maximise savings and plan with confidence for the years ahead- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others
