Clinical Study Activation Specialist

hace 3 días

Santiago, Metropolitana, Chile ENGINEERINGUK A tiempo completo
Job Description

A competitive salary of $65,000 per year awaits a highly skilled Clinical Study Activation Specialist to join our dynamic team at EngineeringUK.

About the Role:

We are seeking an experienced professional to manage start-up activities for assigned studies at the regional level. This includes 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.

Key Responsibilities:
  • Manage start-up activities for assigned studies, including supporting site identification/site recruitment/site selection, central and local submissions, site contracts, essential document preparation, IP release, SIVs readiness, and overall regional site activation readiness.
  • Ensure that clinical delivery project team members and other cross-functional team members understand responsibilities and performance standards, review metrics and other information sources to monitor team and individual performance, and provide feedback to individuals and functional managers as needed.
  • Communicate effectively with project team members to ensure alignment of study start-up strategy and risk mitigation, select appropriate communication platforms to convey information efficiently, and may present at intra- and inter-departmental meetings.
  • Ensure quality standards and applicable regulatory requirements are met in accordance with protocols, guidelines, and local regulations for IP release and site activations.
  • Monitor regional resource allocations for study start-up team members, consult with study start-up project leaders, and escalate issues as needed.
  • Identify and escalate potential risks with regional start-up activities and deliverables, inclusive of proactive mitigation planning.
  • Analyze regional start-up risks and issues, act and document appropriately, and escalate through functional management and study start-up manager.
Required Skills and Qualifications:
  • Bachelor's degree in a business-related, health, life sciences, or other relevant field of study.
  • Broad experience and knowledge with Chilean ethical submissions for start-up studies.
  • Experience in Contract Research Organizations (CROs), Academic Research Organizations (AROs), or pharmaceutical companies.
  • Fluent English language skills, both written and spoken, and fluency in the host country language.
What We Offer:

We prioritize diversity and inclusion, offering a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. Our company is committed to providing a workplace free from discrimination and harassment, promoting equality and respect for all employees. If you need reasonable accommodations during the application process, please let us know. We encourage applicants who believe they can contribute to our success, regardless of whether they meet all the requirements.

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