Study Start Up Associate

hace 6 días

Chile ENGINEERINGUK A tiempo completo

As a Study Start-Up Associate, you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.

You will be part of an innovative and global Biotechnology company, which prides itself on being one of the world's leading independent biotechnology companies. They focus on areas with unmet medical need with the ambition to help reduce the social and economic burden of disease in society today.

The Study Start-Up Associate leads regional clinical study start-up activities to ensure successful activations of investigative sites in accordance with protocol, budget, standard operating procedures, policies, and applicable regulations. Ensures optimal quality delivery for assigned sites' readiness to enroll, meeting sponsor satisfaction to timelines. Proactively identifies and mitigates risks and resolves issues, escalating appropriately.

What you will be doing:
  1. Manage 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.
  2. Ensure that clinical delivery project team members and any other cross-functional team members needed to support regional site activations understand responsibilities and performance standards. Review metrics and other information sources to monitor team and individual performance, providing feedback to individual and functional manager (FM) as appropriate.
  3. Communicate effectively with project team members to ensure alignment of study start-up strategy and risk mitigation. Select appropriate communication platforms to convey information effectively and efficiently. May present at intra-/inter-departmental meetings.
  4. Ensure quality standards and applicable regulatory requirements are met, in accordance with the protocol, applicable guidelines and local regulations for IP release and site activations.
  5. Monitor regional resource allocations for study start-up team members. Consult with study start-up project leaders and escalate as needed.
  6. Identify and escalate potential risks with the regional start-up activities and deliverables, inclusive of proactive mitigation planning.
  7. Conduct analysis of regional start-up risks and issues, acting and documenting in the appropriate system. Escalate as appropriate through functional management and study start-up manager.
  8. Analyze metrics and reports of regional performance against key performance indicators.
You are:
  1. Bachelor's degree in a business-related, health, life sciences, or other relevant field of study.
  2. Broad experience and knowledge with Chile ethical submissions for start-up studies.
  3. Experience in CRO, ARO, or pharma company.
  4. Read, write, and speak fluent English; fluent in host country language.
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.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

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