Senior Clinical Project Manager

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  • Exciting new Biotech
  • Fantastic Product pipeline
  • Rapidly growing team
  • Highly competitive package including flexible working

Are you a Clinical Project Manager or Clinical Study Manager in Oxfordshire? Do you have a solid background in Oncology? Is a rapidly expanding small/mid-sized Biotech of interest to you? Zest Scientific is partnered with a fantastic up-and-coming Biotechnology company with a number of disruptive products in the pipeline. After a highly successful round of funding, they’re seeking a Senior Study Manager to provide Clinical Project Management expertise for their Oncology therapeutic.

 

Your background:

Essential:

  • Life Sciences Degree
  • Multiple years’ experience as a Project Manager or similar in a Clinical or Pharmaceutical environment (approx. 8+ years within Pharma, CRO, Biotech)
  • Experience managing Phase II and III studies
  • A sound background in oncology focussed clinical trials (infectious diseases exposure also desirable)
  • Happy to oversee and manage vendors, with past experience liaising externally
  • Ability to manage a team, and outline project milestones, keeping up to date with deliverables
  • A solid understanding of regulatory requirements (IRB, IEC) and study documentation (protocols, IBs, DSURs, CSRs)
  • Capable of managing budgets according to project plans
  • In depth knowledge of ICH/GCP guidelines
  • Proven experience of developing people in a fast paced environment
  • A keen communicator with a strong affinity to lead
  • No VISA or passport restrictions

 

Highly desirable:

  • Knowledge within the infectious diseases therapeutic area
  • A background in working within companies undergoing significant expansions / scale up

 

Your new role:

  • Provide leadership within the Clinical Operations department of the company
  • Report directly into, and work closely with, the Head of Clinical Operations 
  • Select and assess the suitability of clinical sites for the company’s expanding portfolio
  • Be the lead Study Manager for the company’s up and coming Oncology therapeutic
  • Set up and manage clinical contracts
  • Provide oversight of vendors and external partners from a Study management perspective
  • Prepare study budgets as required and set milestones for the projects undertaken
  • Assist with departmental protocol creations (SOP writing etc.)
  • Develop project plans to ensure milestone deadlines are achieved as per contracts and applicable regulations
  • Give experienced input to the team understanding of Clinical Project requirements
  • Prepare and provide invoicing information as required
  • Be autonomous in leading the department and be accountable for the overall quality and ‘inspection readiness’ of allocated projects
  • Oxford based, with flexible working available

 

The Company:

  • A new and exciting Biotechnology company with a number of exciting products in the pipeline
  • Big expansion plans over the next 18 months, with numerous trials being conducted internationally
  • Well situated in Oxfordshire, accessible from the Science parks of the Slough area etc.

 

The package:

  • In order to secure the services of the best talent in the sector, our client is willing to be negotiable on salary.
  • Package will include: a basic salary and bonus scheme with an option for some flexible home working