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Senior Clinical Trials Specialist - United Kingdom  

Company managed [?] Still accepting applications

Posted on : 09 July 2017

Project Description

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. 


Position Overview
The Senior Clinical Trials Specialist is predominantly 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 10-15% or more of the time 
  • Other duties as assigned 


Requirements:
  • 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 15% (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:
  • Our company  is an equal opportunity employer with European HQ, a professional business park  with several first class amenities such as restaurants, coffee shops, bars, shopping, a health club plus a premier golf course and the country park provides over 160 acres of easy access open space.
  • Our company  offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.