Senior Clinical Trial Specialist

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The Clinical Trial Specialist performs essential responsibilities for successful trial execution for the client. The Clinical Trial Specialist takes on the key role of Study Specialist, contributing to tasks related to site management and/or study management and oversight activities as delegated by SETL, Study Operations Lead (SOL), or Regional Operations Lead (ROL). This may include contributing to and/or supporting study matters that impact study timelines, quality and budget.

The Clinical Trial Specialist can be partly or fully responsible for the following areas depending on his/her level of proficiency. Responsibilities may include, but are not limited to:Quality:· Ensure TMF filing and maintenance is done routinely by Clinical Trial Assistant (CTA)Timelines:· Contribute to the development of vendor specific timelines ensuring alignment with study level timelinesContracts & Budgets:· Review and approve invoices for assigned vendors· Review investigator payment: site setup, pass-through processing, visit payment processing and funding processing in collaboration with DrugDevClinical Operations Managed Vendors & CRO: · May participate in vendor selection· Escalate vendor performance and quality issues to the SOLProtocol & Informed Consent Form (ICF) Development Process:· Create and maintain tracker for future amendment changes· Actively contribute to the review of any changes to the ICF Master· Ensure alignment of country/site specific ICFs with ICF MasterStudy Start Up:· Manage activities related to Startup as delegated by the SOL· Develop study specific documentation as delegated by the SOL· Confirm that all site level documents have been collected to support site initiation· Contribute to the IP release process· Ensure timely study entry and updates to ClinicalTrials.govStudy Conduct And Close-out:· Provide vendor status updates to the Study Operations Lead· Identify and escalate issues relating to study delivery, timelines and site budget to Study Operations Lead· Support study close-out activities (sites, reconciliation activities, filing & archiving)· Participate in data listing reviews· Facilitate timely delivery of clinical documents for the CSR and appendicesInsurance:· Ensure an insurance policy is in place for the country and, if applicable, the individual clinical trial sites associated with the protocol and protocol amendments· Ensure the required information/documents needed to obtain insurance are made available to CTA· Oversee extensions of expiring policies and processing of certificates, as appropriateDrug or Investigational Product (IP):· Support SOL to ensure timely delivery of IP to the sites in collaboration with Clinical Supply Chain (CSC) representative· Ensure that CRO/sites are clear on how IP is to be handled according to pharmacy manualClinical Governance / Team Membership and Leadership: · Attend internal Clinical Operations team meetings, attend vendor meetings as appropriate, based on assignments from SOL· Ad hoc attendance at SET MeetingsThe Clinical Trial Specialist is expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Strategic Thinking, Planning and Analysis, and Problem solving and Decision Making. For example:Responds promptly with clear, organised written and oral communicationSeeks out, and understands the value of, opportunities to interact with peers and stakeholders; builds a network of internal and external peersTakes ownership and accountability for completing assigned tasks and perseveres through obstaclesEmbraces new challenges or changed priorities and adjusts plans and priorities accordinglyThe Clinical Trial Specialist is also in the process of developing foundational technical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge. Education;- BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.- 2+ years pharmaceutical industry experiencePlease click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales