(Sr.) Start-Up Specialist

Labcorp
Πλήρης απασχόληση Γεμάτη μέρα
Αθήνα

Job Overview:


WHO ARE WE?



As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.



Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.



THE JOB



We are recruiting for our Clinical Operations business in Greece and are currently seeking to hire a (Sr.) Study Start-up Specialist who will work with multiple sponsors. This is a permanent, remote and full-time position and you can be based anywhere in Greece.



The seniority and title of the position may vary depending on the experience level of the successful candidate.



Responsibilities include but are not limited to:


  • Primary contact with assigned investigative sites during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study

  • Ensure EC/IRB and any other local applications are made within the timelines agreed with project management and Start-up team and that documentation meets the specifications required by applicable regulations and sponsor

  • Serve as local expert in project start-up activities for a particular country or region

  • Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues

  • Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance

  • Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines

  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner

  • Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion

  • When needed, assist in preparation of Site Activation project specific plans and provide accurate projections and timelines to study teams agreed with the Sponsor Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol

  • Proactively resolve informed consent issues and other potential difficulties with study sites

  • Liaise with Labcorp Drug Development Regulatory department regarding document submission requirements, if applicable

  • Prepare submissions to IRB/IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input

  • Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues. Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Labcorp Drug Development ready for an audit at any time

  • Support or perform the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate


Education/Qualifications:


University/College degree (life science preferred) and minimum 1-year work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations


Experience:


  • Experience in clinical development or start up/regulatory process

  • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites

  • Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them

  • Fluent in Greek and English

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