Study Start-Up Specialist, sponsor-dedicated - Berkshire or Home Office, United Kingdom

Job Description

Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceuticalcompanies are repeat customers!If you are looking to take on responsibility and leverage your know-how in the start-up phase of clinical trials - ensuring a successful start of important clinical studies in the UK -, this is the perfect opportunity. You willbe working alongside our dedicated and supportive team of SSU experts and exclusively for one of our renowned international sponsors - in a role that allows you to have a real impact on peoples health and lives.What we have to offer: a strong internationalsupport network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.While this role can be home-based, you will occasionallybe required to work on site at our clients in Berkshire, UK. If you are not based in this general area, flexibility to travel is therefore required.Your tasks:Serve as the primary contact for investigative sites, proactively managing site activation and providingguidance for your sites during the start-up phase of your assigned studiesEnsure that all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH / GCP, SOPs, budget, quality and all applicable local laws andguidelinesCollect, track and perform a quality review of all essential and investigator documents required for effective and compliant study site activation and maintenanceLiaise with our regulatory department regarding document submission requirements andensure documents required are collected and submitted on time. Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, taking ownership for compliance and audit readinessEscalate any issues with submissions and / orapprovals for your assigned studies appropriately and in a timely fashion, both to internal departments and to external stakeholders such as Institutional Review Boards (IRBs), Independent Ethics Committees (IECs) and UK regulatory authoritiesCustomize countryand site specific patient Informed Consent Forms to ensure compliance with local requirements and protocolSupport the negotiation of site contracts and budgets with study sites and track progress of contract and budget milestones / developments, interveningand escalating as appropriateEducation:Degree in a relevant field such as pharmacology, life sciences, clinical trial management, (veterinarian) medicine, health care (management), nursing, chemistry, biology, oecotrophology etc.,In lieu of the above, an equivalentcompleted vocational education or equivalent professional experienceExperience:Solid expertise in clinical trials within a CRO or a pharmaceutical company with a specialization in clinical study start up / regulatory processesDemonstrated understanding ofresearch protocol requirements as well as the ability to communicate them / educate others about themProven track record collaborating successfully with operational project teams as well as external investigative sites and local regulatory authorities (includingIRBs and IECs)In-depth experience with submissions to the UK regulatory authorities - observing all local regulations and guidelines as well as international standards such as ICH and GCPFamiliarity with investigator start-up documents and contract / budgetnegotiation processes with study sitesAutonomous work style with excellent time and project management skillsBusiness fluency in Englishboth spoken and writtenis a mustREMOTELabcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer,the organization will not discriminate in its employment practices due to an applicants race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.For more information about how we collect and storeyour personal data, please see ourPrivacy Statement.