BrightOwl Loader Loading

Senior Clinical Trials Specialist - United Kingdom  

Kite Pharma (company)


Posted on : 14 April 2017

Project Description

  • Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. 
  • The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
  • Our company  is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs. 
  • The Senior Clinical Trials Specialist is an in-house sponsor position who will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples, enrollment of study participants, as well as scheduling of treatment with investigational product. 
  • The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.


Responsibilities (include but, are not limited to):
  • Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, and relevant study plans and charters) 
  • Works with multiple contract research organizations to communicate detailed timelines and ensure that performance expectations are met 
  • Attends internal team and other meetings 
  • Provides training as necessary at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences 
  • Creates and reviews site feasibility assessments required for study participation 
  • Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations 
  • Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager 
  • Prepares metrics and updates to key deliverables for management 
  • Assists in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks. 
  • Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team 
  • Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol 
  • Participates in the development, review and implementation of departmental SOPs and processes 
  • Travel 25% or more of the time 
  • Other duties as assigned 

  • Bachelor’s degree in nursing, science or health related field required with related clinical trial experience with oncology, haematology or related therapeutic area experience considered a plus 
  • Must be willing to travel at least 25% (possibly more) 
  • Ability to manage time demands, incomplete information or unexpected events, 
  • Must display strong analytical and problem solving skills 
  • Attention to detail 
  • Outstanding organizational skills with the ability to multi-task and prioritize 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities 
  • Working knowledge of transplant patient care and apheresis collection a plus 

About us:
  • We are able to offer the opportunity to be part of this successful, fast growing company. 
  •  A place everyone knows your name and respects your opinion while at the same time offering a competitive benefits package commensurate to any large corporation.