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Senior Clinical Trial Specialist

PE Global
Job LocationLondon
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

The Sr. Trial Specialist is an independent, experienced site management and oversight role for assigned trial(s). Responsibilities focus primarily on oversight of vendor CRAs and mentoring of more junior staff, as well as study/site start-up, maintenance and close-out activities, co-monitoring, and management of other vendors.The individual in this role exhibits foundational level skills related to communication, leadership, strategic thinking, adaptability, flexibility, drug development, and therapeutic area knowledge. S/he has advanced technical skills related to compliance.Responsibilities may include, but are not limited to:Contracts and Vendor Management

  • Manage site budget and contract negotiation, payment, and processing activities in collaboration with the Study Manager, Legal, and Finance
  • Participate in the selection of vendors, support Study Manager in oversight of vendors across assigned trial(s); may include contract negotiation, change orders, budgeting, and meeting facilitation
    • Trial Oversight
  • Collaborate with medical science liaisons (MSLs) and/or regional medical directors to support sites as appropriate
  • Responsible for development of site enrollment plans, start up materials, informed consent document templates (ICD), and other trial related plans (e.g. monitoring plan)
  • Participate in the preparation and finalization of protocols, clinical study reports, and interim reports
  • Responsible for the final review of the site level documentation and approval for initiation
  • Liaise with supply chain for investigational product forecasting at the site level, including shipment and reconciliation activities
  • Responsible for ensuring all supplies required for trial participation by sites are available
  • Responsible for implementation of site feasibility, selection, activation, training, maintenance and close-out activities
  • Responsible for implementation of trial plans for site oversight according to the monitoring plan
  • Communicate with field CRAs and site staff for timely data collection and query resolution
  • Oversee site documentation activities (TMF reconciliation, filing, and archiving)
  • Responsible for adherence to timelines and quality at a site level for assigned trial(s)
    • Data Quality and Compliance
  • Partner with Data Management to coordinate and participate in data reviews to ensure data collection and query resolution occur in a timely manner
  • Collaborate with Pharmacovigilance and Medical Monitor on reconciliation of clinical and safety data
  • Identify and anticipate problems at a site level in collaboration with Field CRAs throughout the life of the trial (i.e., investigator disengagement)
  • Responsible for implementation of corrective and preventative actions resulting from a site audit
  • Identify potential protocol deviations and escalate per protocol deviation plan
    • People Management and Development
  • Train, mentor and support junior staff supporting assigned trials, if assigned
    • CompetenciesThe Senior Trial Specialist demonstrates foundational leadership, communication, and adaptability. For example:
  • Demonstrating willingness and flexibility to achieve a common goal when change occurs
  • Taking ownership of, and accountability for, the completion of assigned tasks, while demonstrating professional maturity
  • An ability to facilitate small (e.g., activity or country specific) meetings, including developing the agenda and completing follow-up, with oversight
    • The individual in this position is expected to demonstrate advanced competence in compliance, along with foundational competence in drug development and therapeutic area knowledge. This includes (but is not limited to):
  • Being adept at recognizing a breach in GCP/GVP and ability to mitigate compliance risks for a clinical trial
  • Understanding the objectives/purpose of each drug development phase
  • Demonstrating basic knowledge of relevant therapeutic areas and disease conditions, particularly in rare diseases
    • Education & Experience
  • BA/BS or higher in life or health sciences preferred. Industry or relevant experience in lieu of education accepted
  • 4 years of relevant experience in clinical science, clinical trial or site management, medical affairs, and/or drug development
  • Some experience mentoring junior staff is preferred
    • Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.

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